Summary

The Research Coordinator II will assume responsibilities for daily activities on Cardio-transplant division-related research protocols, which include team oversight of screening, enrollment, and monitoring of research participants.   Will work closely with the PIs, regulatory staffff, investigational pharmacies, sponsors, and regulatory agencies to ensure that research studies are performed per federal regulations, sponsors' guidelines, and departmental policies. 

This position requires flexibility to work outside normal business hours (Monday–Friday), including occasional weekends, early mornings, and evenings to support clinical research activities.

Job Duties

• Work with the PI  and Regulatory staff 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 the protocol submission process of regulatory documents as required by the protocol. Maintains records. Assist the PI and Regulatory staff with the preparation, review, and submission of documents to the IRB. 
• Establish and organize study files, 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. 
• Collect, process, ship, and maintain paperwork for biological specimens according to procedures outlined in the study protocol.
• Maintain an adequate inventory of study supplies. If handling investigational drugs/devices, follow the sponsor protocol and policies on Investigational Drug/Device Accountability.
• Coordinate appropriate and timely payments to participants following BCM and site-affiliated policies and procedures.
• Perform 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. Attend surgical procedures. 
• Collect data as required by the protocol. Ensure timely completion of Case Report Forms and enters data into EDC. 
• Retrieves and submits test results to the appropriate party.
• Ensures accurate data collection, documentation, organization, and safety of research participants. 
• Assist the Principal Investigator in the submission of event reports, including but not limited to Non-compliance, Adverse Events, and Unanticipated Problems. 
• Keeps track of Protocol Amendments, Clarification letters, and study updates, and implements updates accordingly.
• Attend investigator meetings as required or requested by the PI and/or Sponsor.
• Performs other job duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Bilingual in Spanish strongly preferred.
• Clinical Research Professional certification (ACRP or SOCRA) preferred.
• Lab experience helpful but not required.