Clinical Coordinator Salary in Miami, FL

Job Summary Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Responsible for new research application (including study start-up processes and requirements) and submission of protocols with subsequent amendments. Participates in protocol writing as needed and maintains initial and continuing education for Good Clinical Practice compliance. Job Specific Duties Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate. Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol.  Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance.  Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives. Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff.  Interacts with patients and families to recruit (screen, consent and enroll) study subjects and ensures compliance with the protocol.  Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies. Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format.  Submits amendments of protocols to Research Regulatory Affairs team and verifies the required corrections were inserted following the established procedures. Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol.  Follows NCHS RI’s Standard Operating Procedures, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines.  Enters Research Patient information into CTMS within 72hours of enrollment, patient visit or patient-related event.  Provides new Protocols, Amendments and study status updates to necessary research staff for digitization/entry into CTMS.    Minimum Job Requirements  AA/medical/technical school or 2 years of research and/or healthcare experience required Knowledge, Skills, and Abilities AA or medical/technical school preferred. Experience in pediatric clinical research in a hospital setting preferred. Bilingual in English/Spanish preferred. Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred. Excellent communication skills in working with both children and adults. Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change. Excellent time management skills. Knowledge of protocols and its process. Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment. Experience with relevant hospital equipment for each clinical trial project.  

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The Sylvester Comprehensive Cancer Center has a great opportunity for a Clinical Research Coordinator 3. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study's integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.Coordinates the implementation of multiple complex clinical research protocols.Develops SOPs and templates with guidance from the PI/Clinical Research Manager.Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.Develops and implements preventive/corrective actions. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.Provides leadership in identifying and working through ethical conflicts arising during protocol implementation, and refers these conflicts to the Research Ethics Team for consults as needed.Organizes/manages site visits and internal/external auditing activities as assigned.Coordinates research team meetings; assures communications across-the-board.Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.MINIMUM QUALIFICATIONS: Bachelor's degree in relevant field required.Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 monthsMinimum 4 years of relevant experience required.Skill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work independently and/or in a collaborative environment.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A10

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Psychiatry has an exciting opportunity for a full-time Clinical Research Coordinator 1. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols and timelines.CORE FUNCTIONSPerforms chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Knows the contents and maintenance of study-specific clinical research regulatory binders.Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONSBachelor's degree in relevant field requiredMinimum 1 year of relevant experienceKnowledge, Skills and Attitudes:Skill in completing assignments accurately and with attention to detail.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work evenings, nights, and weekends as necessary.Commitment to the University's core values.Ability to work independently and/or in a collaborative environment.Department SpecificsThe MACS/WIHS Combined Cohort Study (MWCCS) seeks to fill 2 Clinical Research Coordinator 1 position. The primary responsibilities of Clinical Research Coordinator 1 will be data management and implementation of clinical research protocols. In addition, Clinical Research Coordinator 1 will also assist the Recruitment Coordinator in outreach and recruitment efforts for the MWCCS Study and sub studies and report to Dr. Deborah Jones (Medical Campus, Miami).Conducts screening, screening, and baseline interviews at the UM/Jackson HIV Clinic, Converge Miami, and CRB Building.Demonstrate commitment and comfort in working with people with HIV within LGBTQ and HIV-affected communities.Prepare correspondence and answer phones.Coordinate the scheduling of appointments and study visits.Able to be outgoing and comfortable talking to or approaching people on sensitive personal topics in bars, clubs, clinics, health agencies, etc.Helps observe and report adverse events to the PI/supervisor, including those documented by study participants.Establishes networking opportunities in academic and community spheres to promote opportunities for collaborative recruiting efforts.Able to commute and work evenings, nights, and weekends as needed.Participates in community events and distributes appropriate recruitment materials.Maintain University standards when handling participant information and data.Assists in organizing and executing meetings, events, and educational activities for community partners, staff, and faculty members.Address adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.Maintain required skills and mandatory training in security, equality, responsible conduct of an investigation, and continuing education.Monitors petty cash for study visits and purposes.Adhere to University and unit policies and procedures and safeguard University assets.Completes other duties as assigned.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A8

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 3 to work in Miami, FL. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study's integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.CORE JOB FUNCTIONS 1. Coordinates the implementation of multiple complex clinical research protocols.2. Develops SOPs and templates with guidance from the PI/Clinical Research Manager.3. Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.4. Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.5. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.6. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.7. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.8. Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.9. Organizes/manages site visits and internal/external auditing activities as assigned.10. Coordinates research team meetings; assures communications across-the-board.11. Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.12. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.15. Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONS Education:Bachelor's degree in relevant fieldCertification and Licensing:Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 monthsExperience: Minimum 4 years of relevant experienceDEPARTMENT ADDENDUMDepartment Specific FunctionsPurpose:Clinical and outcomes research, coordination with translational and social science research; management of complex research data collection infrastructure; coordination and organization for clinical research involving patients with chronic and serious illness.Position dimensions include:Interfacing across departments; working with research subjects; data infrastructure management; helping with the development of research publications; contributing to grant applications; involvement with sponsored studies, training and supervision of research assistants and trainees.Working Environmental Conditions:Working on a collaborative research team with the PI, research assistants, and collaborators; liaison with informational technology and electronic medical record personnel; direct subject contact for consents and longitudinal follow-up, focus groups; videoconferencing meetings and in-person meetings.The majority of work will be on the main UM medical campus with occasional travel to satellite clinics. May require intermittent evening or after hours commitments.Department Specific Qualifications Education:Minimum education: experience in Medicine, Health Services, Public Health, or related fields. Graduate education encouraged.Advanced Spanish Language and English fluency required.Certification and Licensing:Must have or obtain compliance with all Research certifications, including Good Clinical Practice and Blood borne pathogens.Appropriate certifications and training in consenting patients, clinical research ethics, and regulatory research managementExperience:3 or more years of minimum work experience in: Direct patient research, including consenting, quantitative methodological skills, database management, and experience with clinical research regulatory compliance.Capacity to independently run day-to-day operations for complex research studies. Experience working with patients.Knowledge, Skills and Attitudes:Contributes to clinical and applied research activities including data collection, consenting patients, longitudinal patient follow-up, subject tracking, maintaining regulatory compliance, IRB submissions and modifications, and authors technical and agency reports.Collaborates with the PI and senior staff on the development of research publications.Creates and conducts clinical research and basic descriptive analysis of the results.Manages clinical databasesRun day-to-day operations for large complex research studies, including PI-driven research, grant-funded research, and sponsored studiesAssists the PI and senior staff in preparing materials for submission to granting agencies and foundations.Provides ready access to all experimental data for senior staff and research teamRequests or acquires equipment and supplies for assigned project(s).Uses the Internet, surveys, databases, electronic medical record, and other available sources to collect research information.Interfaces across departments with research collaborators, and funding agencies.Participation in new skill developmentAssist with qualitative research Skill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work independently and/or in a collaborative environment.#ED-LI1The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A10

Job Summary Assumes clinical and organizational responsibility for the clinical team, so as to provide the best possible quality of care for each patient. Job Specific Duties Assists physician during clinic hours.  Assists physician with nursing and/or administrative tasks for successful operative and clinic cases including basic wound care, suture removal, and dressing changes. Collaborates with a multidisciplinary team to coordinate patient care including multidisciplinary outpatient appointments.  Responsible for patient and family education needs analysis, family education, and teaching, and customizing the information to assist with problem resolution.  Coordinates scheduling of operative cases.  Leads the coordination of complex care from admission to outpatient follow up, including participation in patient clinical rounds and follow up on inpatient care.  Responsible for coordinating treatment plans and goals for team and having these incorporated into the patient's treatment.  Serves as liaison between clinicians and patients and is responsible to communicate with the medical and nursing staff and leaders on the coordination of care and patient and family support.  Informs staff of any changes that affect their daily workflow to ensure complete communication within the service area and avoid any errors.  Responsible to communicate with families regarding prescriptions, referrals, and any documentation needed for successful treatment.  Performs service recovery when applicable to maximize the patient and family experience.  Coordinates patient discharge after clinic when applicable, provides follow up appointments as needed, and updates EHR when necessary. Minimum Job Requirements Bachelor's Degree in Nursing from an accredited school of nursing RN Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) – maintain active and in good standing throughout employment American Heart Association BLS - maintain active and in good standing throughout employment 1-3 years of experience in a pediatric setting Knowledge, Skills, and Abilities Bilingual: English/Spanish preferred. Ability to quickly coordinate the interdisciplinary team so that patient goals and best patient outcomes are achieved. Good organizational and time management skills. Intermediate skill in Microsoft Office: Word, Excel, PowerPoint.

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The Department of Dermatology has an exciting opportunity for a full-time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Knows the contents and maintenance of study-specific clinical research regulatory binders.Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.MINIMUM QUALIFICATIONS Bachelor's degree in relevant fieldMinimum 1 year of relevant experienceSkill in completing assignments accurately and with attention to detail.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work evenings, nights, and weekends as necessary.Commitment to the University's core values.Ability to work independently and/or in a collaborative environment.DEPARTMENT SPECIFIC FUNCTIONSCompletes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.Create and design appropriate templates as Source Documents for Sponsor Initiated and Investigator initiated Studies.Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.Manage coordination of facilities monitoring, auditing visits, site evaluations and Initiation visits.Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants.Establishes/maintains contact with patient/participants, health care providers, community agencies and study sponsors.Minimum 3 years of experience (preferred)Clinical coordinator certification (preferred)The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A8

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The Department of Pathology is currently seeking a full time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.CORE JOB FUNCTIONS Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.Maintains enrollment procedures according to the protocol.Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Knows the contents and maintenance of study-specific clinical research regulatory binders. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONS Education:Bachelor's degree in relevant fieldExperience: Minimum 1 year of relevant experienceDEPARTMENT ADDENDUMDepartment Specific FunctionsThe Department of Pathology and Laboratory Medicine (DPLM) is a growing multi-disciplinary department at the University of Miami Miller School of Medicine. It encompasses 4 distinct divisions: Anatomic Pathology, Hematopathology, Comparative Pathology, and Laboratory Medicine. DPLM Research includes all divisions and is divided according to basic, translational, and clinical research.The position of Clinical Research Coordinator 1 @DPLM is expected to:Plan, implement, and monitor pathology clinical research study requests requesting pathology specific services Review protocols for laboratory requirements, including drafting and designing project budgets plans for requested servicesMaintain frequent and collaborative customer focused relationships with the research team member and works effectively with Principal Investigators in the design of budget preparationParticipate in the development and revision of internal Standard Operating Procedures (SOP) in the delivery of pathology servicesConduct all pathology research related requests, which includes searches using coPath, and managing faculty research databases using several software such as Qualtrics, Sharepoint, and REDCap Keep faculty individual databases to capture all consult cases databasesParticipate and coordinate new pathology research project such as ImageneKnowledge, Skills and Attitudes:Skill in completing assignments accurately and with attention to detail.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work evenings, nights, and weekends as necessary.Commitment to the University's core values.Ability to work independently and/or in a collaborative environment.#ED-LI1The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A8

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 1 to work in Miami, FL. The Clinical Research Coordinator provides professional level support for research clinical studies involving human subjects and assists in the design of studies, generation of databases, and update and maintenance of documentation. Moreover, the Clinical Research Coordinator develops, verifies, and implements procedures to accomplish research goals.CORE JOB FUNCTIONS 1. Coordinates routine activities of clinical studies including data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing. 2. Tracks medical reports and reviews regulatory documents to generate reports. 3. Serves as project liaison to other departments, outside organizations, government agencies, and product representatives. 4. Recruits patients into the study and reviews on a weekly basis the percentage recruited.5. Reviews data collected and inserts into the study dataset. 6. Compares the data collected to the monitored phone calls for data quality assurance.7. Evaluates and monitors timelines for studies and for each subject participant to comply with applicable protocols.8. Prepares materials for the brochures and retaining letters and mails to appropriate members according to their time in the study.9. Administers informed consent forms for patients on drug studies.10. Maintains pool of study candidates and ensures their availability.11. Coordinates the necessary testing for patient evaluations per physicians' orders and study protocol requirements.12. Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONS Education:Bachelor's Degree in relevant fieldExperience: Minimum 3 years of relevant experienceDEPARTMENT ADDENDUMDepartment Specific Functions1. Managing the StudyIndependently performs chart review/pre-screening for eligibility and coordination of simple clinical research protocols.Maintains all logs, including Velos entry according to UM and department SOPs.Assists planning study timelines and schedules appointments and study visits.Manages and organizes case report forms, source documents and research records.Conducts data collection activities according to established operational procedures and timelines.Assists in observing and informing the PI/supervisor in a timely manner of adverse events, including those reported by study participants.Fully adheres to established procedures, policies, and standards in implementing clinical research protocols.Adheres to continuous research quality improvement practices.Maintains safety, environmental, and/or infection control standards throughout job duties.Assists in entering research data into data collection forms and/or study databases.Assists in conducting quality checks for data accuracy with data source records as assigned.Increases understanding of and interpreting moderately complex clinical study designs, research protocols, and procedures.Executes simple clinical research protocols and may assist CRA1/CRDS in fundamentals.Exhibits increasingly sound judgment in planning/performing research protocols for optimal quality research.2. Research Regulatory Compliance and Human Subject's ProtectionFollows fundamentals of Good Clinical Practice (GCP) per E6 guidelines of the International Conference of Harmonization (ICH)Follows the fundamentals of conducting clinical research under the appropriate federal and local regulations.Follows the fundamental requirements for adverse event assessment, documentation, and reporting.Follows the principals of informed consenting process and documentation.Obtains study-specific clinical research protocol and research-related procedures training. Assists others in same.Knows the contents and maintenance of study-specific clinical research regulatory binders.Ensures and adheres to standards of protecting clinical research data and study participant private information according to HIPAA and regulatory privacy requirements.Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.Participates in site visit and internal/external auditing activities as assigned.Assures own adherence to safety and responsible conduct of research standards. Assist others in same.Follows established policies, procedures, continuous research quality improvement practices, and safety, environmental, and/or infection control standards throughout research protocol, problem solving and following through about unanticipated occurrences.3. Maintaining Study Continuity and Coordinating Logistics, Research Procedures, and Study ParticipantsParticipates in pre-screening activities for study participant eligibility, maintaining enrollment procedures according to the protocol.Observes, reports, and facilitates positive study participant responses, minimizing deviations.Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.Performs testing and data collection activities according to established operational procedures and timelines.Observes for deviations and takes action to minimize them. Reports deviations when they occur, addressing adverse events with supervision.Shows increasing organizational skills to facilitate full adherence to timelines.Continues to learn how to recognize and report logistical challenges in protocol implementation to the research team, assisting in resolving challenges.Assists in identifying and developing data collection tools. Assists the CRA 1 in simple data tasks.Performs quality checks for data accuracy, reports/follows-up with discrepancies.Effectively collaborates with clinical services/departments to plan, implement, and evaluate study protocols.4. Contributing to the ScienceAdheres to standards of excellence in scientific methods applied to protocol implementation.Learns and values the importance of quality research standards, identifies personal role in advancing them, and assists in helping others in same.5. Professional DevelopmentMaintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Maintains CITI and Conflict of Interest (COI) certification and renewal as required.Gains knowledge in medical research terminology.Continues to gain proficiency in UM-specific research software needed to manage clinical research protocols.Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards. Assists in helping others in same.Participates in protocol-related training as required.Performs other duties as assigned.Knowledge, Skills and Attitudes:Skill in completing assignments accurately and with attention to detail.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work evenings, nights, and weekends as necessary.Commitment to the University's core values.Ability to work independently and/or in a collaborative environment.#ED-LI1The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A8

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Psychiatry has an exciting opportunity for a Clinical Research Coordinator 3 to work onsite on the UHealth campus. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study's integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.CORE FUNCTIONSCoordinates the implementation of multiple complex clinical research protocols.Develops SOPs and templates with guidance from the PI/Clinical Research Manager.Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.Organizes/manages site visits and internal/external auditing activities as assigned.Coordinates research team meetings; assures communications across-the-board.Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONSBachelor's degree in relevant fieldCurrent Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 monthsMinimum 4 years of relevant experienceKnowledge, Skills and Attitudes:Skill in collecting, organizing, and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize, and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work independently and/or in a collaborative environment.Oversee the management of specific research requirements within the department. This includes coordinating with principal investigators and regulatory bodies to ensure smooth protocol implementation, participant recruitment, and data collection.Implement quality assurance measures to ensure the integrity and reliability of research data within the department. This could involve developing standardized procedures, conducting regular audits or reviews, and implementing corrective actions as needed.Assist in the development and review of research protocols within the department. This could involve providing input on study design, feasibility assessments, and protocol revisions to ensure scientific rigor and compliance with regulatory standards.Oversee data management and analysis activities for research projects within the department. This could include developing data collection tools, ensuring data quality and completeness, and collaborating with biostatisticians or data analysts for data analysis.Assist in grant proposal development and budget management for research projects within the department. This could involve preparing grant applications, tracking project expenditures, and ensuring compliance with funding agency requirements.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A10

Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Psychiatry has an exciting opportunity for a Clinical Research Coordinator 1 to work onsite on the UHealth campus. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols and timelines.CORE FUNCTIONSPerforms chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.Knows the contents and maintenance of study-specific clinical research regulatory binders.Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.Adheres to University and unit-level policies and procedures and safeguards University assets.This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.CORE QUALIFICATIONSBachelor's degree in relevant field requiredMinimum 1 year of relevant experienceKnowledge, Skills and Attitudes:Skill in completing assignments accurately and with attention to detail.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work evenings, nights, and weekends as necessary.Commitment to the University's core values.Ability to work independently and/or in a collaborative environment.Department SpecificsThe CRC 1 will report to Dr. Vilma Gabbay and serve on projects with a multidisciplinary and collaborative team. Projects include innovative MRI-based imaging approaches, investigations of neuroinflammation, and the use of behavioral paradigms to probe reward processing in mood and anxiety disorders in adults and adolescents. CRC 1s will have the opportunity to gain excellent clinical and research experience, with the potential for publication.The coordinator will handle the process of conducting research studies and related projects. Responsibilities include any combination of research participant-related activities such as recruitment, screening, psychiatric assessment, data collection, analysis, and management using electronic data capture systems, interaction with patient's treatment team, imaging acquisition, and preparation of manuscripts. The CRC 1 will ensure that studies are conducted according to protocol design and will report deviations as they arise, and maintain study files such as regulatory documents, correspondence, case report forms and data files. They will perform activities related to regulatory compliance such as IRB submissions, mandates issued by the study sponsor, and any other regulatory entity.The ideal candidate for this position will have a strong background in neuroscience or psychology with previous research experience. The position will be hybrid with the option to do fieldwork in either New York City or Miami, and involves a five day work week that may include weekend effort.The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:Full timeEmployee Type:StaffPay Grade:A8