Clinical Research Coordinator 1

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The department of Pediatrics has an exciting opportunity for a Full Time Clinical Research Coordinator 1 to work at UHealth. 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. Provides professional level support for research studies. Determines data to be collected and develops forms for collections/summarizing data. Establishes and maintains contact with patient participants, health care providers, community agencies, study sponsors. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines. This position is supervised by the Chief of the Division of Pediatric Gastroenterology, Hepatology and Nutrition.

• Provides professional level support for research studies and assists in the design of studies.

• Develops, verifies, and implements procedures to accomplish research goals.

• Implements research protocol and monitors participant adherence to protocol.

• Verifies accuracy of research data and monitors data quality control.

• Prepares and submits annual reviews to the Institutional Review Board (IRB).

• Maintains consent forms and sponsor correspondences. Notifies IRB of protocol amendments, safety reports and serious adverse events, etc. in compliance with applicable regulations.

• Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.

• Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants. Maintains drug accountability records for study drugs.

• Determines data to be collected and develops forms for collecting/summarizing data.

• Maintains and assists clinical research computer database and enters data onto case reports and/or into database as appropriate.

• Ensures data integrity and consistency in computer database and written records.

• Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed.

• Establishes/maintains contact with patient participants, health care providers, community agencies and study sponsors.

• Updates appropriate agencies (such as sponsors, IRB, etc.) regarding status of research project. Provides in-service education to staff and patients/participants about research protocols.

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

• Bachelors degree required.

• Minimum 1 year of relevant experience

Knowledge, Skills, and Attitudes:

• Computer skills related to data management required.

• Data analysis skills and basic understanding of statistics.

• Ability to work independently and collaborate with a team.

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.

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