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JOB DESCRIPTION

Position Title:
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Clinical Affairs Specialist


RA/CA
VP, RA/CA
Exempt
3241 3244
Clinical Research Associates

Summary:
Design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and
investigators and by ensuring compliance with study protocols, FDA and International regulations, IRB and/or Ethics
committees requirements and overall clinical objectives.
Essential Duties and Responsibilities:

Under the direction of the Manager of Clinical Affairs, implement clinical research projects.

Oversee patient screening and enrollment at assigned clinical study sites.

Monitor ongoing compliance to study protocols.

Work with investigators to quickly and effectively resolve discrepancies.

Review source documentation, case report forms, and data reports for accuracy and ensure the timely
submission of such documentation.

Perform site training to ensure compliance to the Investigation Plan.

Develop materials for clinical training sessions.

Coordinate meetings with site coordinators and investigators.

Identify and prepare written reports as required.

Ensure accurate inventory of investigative devices.

Regularly recognize problems and recommend corrective and preventive action.

Supports development of the Design and Process FMEA.

Identifies hazards and mitigating risk associated with identified hazards in Design and Process FMEA and
determining severity of the harms associated with identified hazards.

Evaluates product history data based on customer complaint records, results of controlled investigations and
published literature for the device or similar devices, if applicable.

Attend relevant scientific and/or medical meetings.

30 to 50% travel.
Education, Training, Skills and Experience Requirements:

Minimum of 2 to 5 years experience with a Clinical trial experience with Medical Devices is preferred.

Requires a Bachelors degree in a scientific discipline, RN or BSN degree or equivalent

Knowledge of FDA regulatory requirements related to the conduct of clinical studies.

Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors

Exercise good judgment within generally defined practices and policies in selecting methods and techniques for
obtaining solutions.

Normally receives no instructions on routine work, general instructions on new assignments.


Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully
perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly
required to stand; walk, and sit for extended periods of time.
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