Clinical Research Coordinator - Department of Medicine Clinical Research Unit - Grant Funded

Carilion Clinic • Roanoke, VA

124d

About The Position

Under minimal supervision of the Principal Investigator, assists with administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy.

Requirements

• Bachelor's Degree in Biology or Medical/Clinical Sciences or a related field required.
• Four (4) years experience in clinical research may be substituted for education.
• 3 years in healthcare or research.
• Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required within 12 months of hire.
• I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
• Excellent computer skills; strong knowledge of word processing, spreadsheets, databases, and internet environment.
• Knowledge of medical and/or pharmaceutical terminology strongly desired.
• Strong organization and communication skills required.
• Able to work with multiple interruptions and to perform multiple tasks at any given time.

Responsibilities

• Recruit, screen, and enroll eligible study participants.
• Obtain informed consent from study participants.
• Manage completion and submission of study related documentation.
• Communicate with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
• Assist in monitoring enrollment goals.
• Coordinate tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team.
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Collect, process, and ship research specimens as directed in the protocol.
• Ensure compliance with study protocol and requirements of regulatory agencies.
• Track and report adverse events and protocol deviations.
• Coordinate all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure.
• Under supervision, prepare, submit, and maintain IRB, R D, FDA and/or any other funding or regulatory documents and research correspondence.
• Develop and maintain patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log.
• Demonstrate competency managing complex studies.
• Provide basic skills training for CRC Is and Clinical Research Assistants.

What This Job Offers

• Job Type: Full-time
• Industry: Hospitals
• Education Level: Bachelor's degree