Clinical Research Coordinator

at  Prisma Health

JOB SUMMARY

Under minimal supervision, assists with screening, consents, enrollment and maintaining research subjects as well as maintain compliance to research protocols. Acts as the liaison between monitors, investigators and study personnel regarding all data management for patients enrolled in clinical trials. Responsible for abstraction of accurate, complete and timely data from the medical record, as needed. Maintains protocol regulatory documents in compliance with SOPs. Provides a safe environment for patients, families and clinical staff.

ACCOUNTABILITIES

• Independently compiles the medical records of research subjects during the on-study, treatment and follow-up periods and reports required elements to the research sponsor in a complete, accurate and timely manner. Ensures protocol compliance and accurate data submissions during the treatment and post treatment phase of a research trial. Ensures that research tasks are completed correctly by referencing the most current copy of the research protocol and by accessing the research sponsor resources to complete tasks. Ensures compliance with regulatory requirements throughout the study process. Maintains accurate data on research patients in the research department database. Ensures medical record accurately reflects research billing guides. 30%
• Develops and maintains a systematic approach to ensure all research data is reported in the time frame specified by the protocol. Performs query resolution in a timely manner. 20%
• Performs tasks associated with enrollment and active treatment period of research subjects. Collects and ships research specimens, gathers and submits radiological scans, performs clinical procedures such as EKGs as required by the research sponsor. Assists in ensuring investigational drugs are maintained and distributed according to the protocol and FDA guidelines. 20%
• Assists research nurses in screening, consenting, and re-consenting research subjects. 10%
• Prepares research records and participates in monitor visits or audit inspections. Participates in protocol specific training (initiation visits) conducted by the sponsor. Facilitates communication between the study sponsor, research nurses and investigators. 20%

MINIMUM EDUCATION

Associate’s Degree- Clinical, healthcare or scientific related field required

MINIMUM EXPERIENCE

3 years- Allied health, medical or research related experience

IN LIEU OF THE ABOVE MINIMUM REQUIREMENTS

BS degree in clinical, healthcare or scientific related field required and 1 yr of experience

OTHER REQUIRED EXPERIENCE

SoCRA or ACRP certification- Preferred
Oncology medical research experience- Preferred
Some medical office experience preferable in oncology- Preferred
Medical terminology knowledge- Preferred

This is a non-management job that will report to a supervisor, manager, director or executive.