Research Coordinator III

Summary

The Division of Cardiothoracic Transplant and Circulatory Support at Baylor College of Medicine is seeking a Research Coordinator III with plenty of experience in clinical studies involving heart transplants and Ventricular Assist Devices. This individual is responsible for the coordination of research studies' daily activities, which will include scheduling, screening, enrollment, randomizing, and monitoring of research participants. The Coordinator will work closely with the PIs, regulatory staff, investigational pharmacies, sponsors, and regulatory agencies to ensure that research studies are performed per federal regulations, sponsors' guidelines, and departmental policies.

Job Duties

• Works with the Principal Investigator (PI) to assure that the study complies with all terms and conditions, including but not limited to education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff, and any financial terms or conditions.
• Assists with protocol approval process and submission of regulatory documents as required by the protocol.
• Maintains records and regulatory documents.
• Assists the PI with regulatory affairs activities and the preparation, review, and submission of documents to the IRB. Keeps track of Protocol Amendments, clarification letters and study updates and implements updates accordingly.
• Establishes and organizes study files, including regulatory binders, study-specific source documentation, and other materials.
• Interviews, screens, and consents patients for study; explains process and procedures to educate participants regarding the research study.
• Collects patient information; processes documents and enters information into a database.
• Ensures timely completion of Case Report Forms and enters data into EDC.
• May collect, process, ship, and maintain paperwork for biological specimens according to procedures outlined in the study protocol.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follow the sponsor protocol and policies on Investigational Drug/Device Accountability.
• Coordinates appropriate and timely payments to participants following BCM and site affiliated policies and procedures.
• Performs billing reconciliation in EPIC when research procedures are paid by the study.
• Schedules research participants for tests and procedures such as laboratory tests, x-rays, and other studies specific to the research protocol.
• Attends surgical procedures. 
• Ensures accurate data collection, responds to data queries, redacts and organizes documentation accordantly.
• Assists the PI in the submission of event reports, including but not limited to non-compliance, adverse events, and unanticipated problems. 
• Attends meetings as required or requested by the PI and/or Sponsor.
• Corresponds with IRB, Sponsor and Monitors.
• May supervise and train other research staff.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree
• Previous experience coordinating cardio-thoracic studies.
• Ability to work independently with minimal supervision and have flexibility to occasionally work irregular hours.
• Ability to demonstrate knowledge of regulatory affairs and IRB processes.
• Cardio-thoracic and database management.

• Current certification (Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC) from a clinical research organization (SoCRA or ACRP).
• Bilingual in English/Spanish is a plus but not required.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

5906

CA; CH