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

Carilion Medical Center•Roanoke, VA

About The Position

Under general supervision of the Principal Investigator, the Clinical Research Assistant 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. This position will be assigned to support minimal risk or non-interventional studies, unless assigned to serve in a support function for greater than minimal risk studies that also include a Clinical Research Coordinator or Clinical Research Nurse Under supervision of Principal Investigator, assist in overseeing compliance to research protocols. Assists with completion and submission of study related documentation. Communicates with study team, research sponsor or CRO, local or central IRB, Office of Sponsored Projects, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. Assist in monitoring enrollment goals. Coordinates tasks related to research subjects such as assisting with development of informed consents and screening materials, scheduling visits, obtaining informed consent, and acting as a liaison between research participants and the research study team. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Collect research specimens as directed in the protocol. Ensure compliance with protocol guidelines and requirements of regulatory agencies. Tracks and reports adverse events and protocol deviations. Under supervision of Principal Investigator, coordinates all site related monitoring or auditing visits from sponsor and/or federal agency during the course of the study and at closure. Prepares, submits and maintains IRB, OSP, FDA and/or any other funding or regulatory documents and research correspondence. Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, and enrollment logs.

Requirements

Bachelor's Degree required.
Bachelor's degree in science or a related field required.
Three (3) years of experience in clinical research may be substituted for education.
1 year in healthcare or research preferred.
IATA required with hire.
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.

Nice To Haves

1 year in healthcare or research

Responsibilities

Assist in overseeing compliance to research protocols.
Assists with completion and submission of study related documentation.
Communicates with study team, research sponsor or CRO, local or central IRB, Office of Sponsored Projects, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance.
Assist in monitoring enrollment goals.
Coordinates tasks related to research subjects such as assisting with development of informed consents and screening materials, scheduling visits, obtaining informed consent, and acting as a liaison between research participants and the research study team.
Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
Collect research specimens as directed in the protocol.
Ensure compliance with protocol guidelines and requirements of regulatory agencies.
Tracks and reports adverse events and protocol deviations.
Coordinates all site related monitoring or auditing visits from sponsor and/or federal agency during the course of the study and at closure.
Prepares, submits and maintains IRB, OSP, FDA and/or any other funding or regulatory documents and research correspondence.
Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, and enrollment logs.