Clinical Research Coordinator (A)
Clinical Research Coordinator (A)
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Job Description
Current Employees:
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The Department of Surgery has an exciting opportunity for a Clinical Research Coordinator 1 position. The incumbent 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
Bachelors degree in relevant field
Minimum 1 year of relevant experience
DEPARTMENT ADDENDUM
Department Specific Functions
Coordinates routine activities of clinical studies including data maintenance grant expenditure adherence project evaluation meeting scheduling and research subject interfacing. Tracks medical reports and reviews regulatory documents to generate reports. Serves as project liaison to other departments outside organizations government agencies and product representatives. Recruits patients into the study and reviews on a weekly basis the percentage recruited. Reviews data collected and inserts into the study dataset. Compares the data collected to the monitored phone calls for data quality assurance. Evaluates and monitors timelines for studies and for each subject participant to comply with applicable protocols. Prepares materials for the brochures and retaining letters and mails to appropriate members according to their time in the study. Administers informed consent forms for patients on drug studies. Maintains pool of study candidates and ensures their availability. Coordinates the necessary testing for patient evaluations per physicians orders and study protocol requirements. Adheres to University and unit-level policies and procedures and safeguards University assets.
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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 Floridas 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. Were the challenge youve been looking for.
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:
A9Required Experience:
IC
Employment Type
Full-Time
