Clinical Research Assistant, Aortic Center

Under general 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. Maintains compliance with guidelines set by governing agencies and institutional policy. This position will be assigned to serve in a 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. This person will be assigned to the Aortic Center focusing on vascular surgery. The primary responsibility of this CRA will be to work on investigator-initiated research developing and utilizing the FEVAR database. This is an ideal position for a self-motivated individual interested in pursuing a career in medicine.

• 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.

Education: Bachelor's Degree required. Bachelor's Degree in Science or a related field required. Three (3) years experience in clinical research may be substituted for education.

Experience: 1 year in healthcare or research preferred.

Licensure, certification, and/or registration: IATA required with hire.

Other Minimum Qualifications: 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.

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