Research Coordinator II - Surgery

Summary

The Research Coordinator II will manage daily activities for Cardiothoracic division research protocols, overseeing screening, enrollment, and monitoring of participants. The role works closely with principal investigators, regulatory staff, investigational pharmacies, sponsors, and regulatory agencies to ensure compliance with federal regulations, sponsor guidelines, and departmental policies. Schedule flexibility is offered based on study needs, with occasional early mornings or evenings required to support patient consent and surgical schedules. Visa support is available, and TN visa candidates are encouraged to apply.

Job Duties

• Work with the PI and regulatory staff to assure study compliance with IRB approval, conflict‑of‑interest disclosure, health and safety protections, and financial terms.
• Assist with the protocol submission process of regulatory documents and maintain study records.
• Prepare, review, and submit documents to the IRB.
• Establish and organize study files, source documentation, and other materials.
• Interview, screen, and consent patients; educate participants about the research study.
• Collect patient information, process documents, and enter data into a database.
• Collect, process, ship, and maintain paperwork for biological specimens according to protocol procedures.
• Maintain an adequate inventory of study supplies; follow sponsor protocols for investigational drug/device accountability.
• Coordinate appropriate and timely payments to participants following BCM and site‑affiliated policies.
• Perform billing reconciliation in EPIC when research procedures are paid by the study.
• Schedule research participants for tests and procedures such as laboratory tests, x‑rays, and other protocol‑specific studies.
• Attend surgical procedures and collect data as required by the protocol.
• Ensure timely completion of case report forms and enter data into the electronic data capture system.
• Retrieve and submit test results to the appropriate parties.
• Ensure accurate data collection, documentation, organization, and safety of research participants.
• Assist the PI in submitting event reports, including non‑compliance, adverse events, and unanticipated problems.
• Track protocol amendments, clarification letters, and study updates; implement updates accordingly.
• Attend investigator meetings as required or requested by the PI and/or sponsor.
• Perform other job duties as assigned.

Minimum Qualifications

• Bachelor’s degree in a related field (or four years of related experience in lieu of a degree).
• At least one year of relevant experience.

Preferred Qualifications

• Master’s degree or Medical Degree.
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) from SoCRA or ACRP.
• Ability to work regular business hours with occasional early mornings, evenings, or weekends as required by study protocols.
• Effective oral and written communication with internal and external collaborators.
• Proficiency with computer software and applications, including Microsoft Office and front‑end database applications (RedCap, EPIC, Medidata, Oracle).
• Demonstrated problem‑solving skills, initiative, and ability to meet deadlines set by manager or PI.

Other Working Conditions

• Work is performed primarily in an office environment with periodic visits to clinical and off‑site areas for patient interviews.
• Physical demands include moderate lifting; ability to sit, stand, and walk for prolonged periods; ability to read papers and online documents; ability to operate standard office equipment; and maintaining perspective acuity to satisfactorily perform essential job functions.