Summary

The Research Coordinator II will assume responsibilities for daily activities on Cardiothoracic division-related research protocols, which include oversight of screening, enrollment, and monitoring of research participants. 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.

This role offers schedule flexibility based on study needs and may require occasional early mornings or evenings to support patient consent and surgical schedules.

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 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

• Master's degree or Medical Degree.
• Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC) from a clinical research organization (SoCRA or ACRP).
• While the standard schedule will be regular business hours, there may be times when early mornings, evenings, or weekends are required based on the study protocol.
• Must be able to communicate effectively and in a professional manner, both orally and in writing, with internal and external collaborators.
• Experience with computer software and applications, including Microsoft Office and front-end database applications (RedCap, EPIC, Medidata, Oracle).
• Demonstrates problem-solving skills, takes action and meets deadlines assigned by Manager and/or PI.

Other

Working Conditions

• Work is performed primarily in an office environment but may require periodic visits to clinical and off-site clinical areas for purpose of interviewing patients.

Physical Demands

• Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.