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 Principal Investigators (PI)s, regulatory staff, investigational pharmacies, sponsors, and regulatory agencies to ensure that research studies are performed per federal regulations, sponsors' guidelines, and departmental policies.

While we will attempt to provide flexibility to work early mornings, late evenings, and weekends as necessary, there will be times when the work schedule is dictated by the study protocol.
Must be able to communicate effectively and in a professional manner, both orally and in writing, with internal and external collaborators.

Job Duties

• Performs billing reconciliation in EPIC when research procedures are paid by the study.
• Schedules resarch participants for test and procedures such as laboratory test, x-rays, and other studies specific to the research protocol.
• Attends surgical procedures.
• Collects data as required by the protocol. Ensures 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.
• Assists the Principal Investigator (PI) 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.
• Attends investigator meetings as required or requested by the PI and/or Sponsor.
• Perform other 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

• Experience with computer software and applications, including Microsoft Office and front-end database applications (RedCap, EPIC, Medidata, Oracle).
• Demonstrated problem-solving skills, ability to take action and meets deadlines assigned by Manager and/or PI.
• Bilingual in English/Spanish.