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Medical University of South Carolina UNIV - Program Coordinator I - Surgery: Transplant Surgery Research in Charleston, South Carolina

FLSA: Hourly

Job Summary: The Department of Surgery, Division of Transplant Surgery Research is currently recruiting for a Program Coordinator I to assist with clinical trials.

Job Duties:

  • 20% - Supervise and manage day to day clinical trial operations. - (Essential)

  • 20% - Ensure study-required clinical elements and tests are conducted and collected according to the protocol. - (Essential)

  • 15% - Submissions to IRB to be prepared according to regulations and deadlines including: applications, renewal, adverse events, write informed consent document and amendments, protocol amendments. - (Essential)

  • 15% - Case Reports Forms and source documentation to be completed and maintained accurately, truthfully and timely. - (Essential)

  • 10% - Obtain informed consent under the direction of the Principle Investigator and maintain accurate informed consent documents for later review. - (Essential)

  • 10% - Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA or internal auditing. - (Essential)

  • 5% - Travel to Sponsor initiated investigator meetings with investigator to review protocols for initiation and to review clinical findings during a trial as needed. - (Essential)

  • 5% - On-call responsibilities on a rotational basis with others in the department. Will be a resource for all clinical needs and available to answer study related questions or talk with patients about study participation. - (Essential)

Preferred Experience & Additional Skills: Works independently with minimal supervision. Must exercise judgment and discretion. Establish and maintain effective working relationships. Must be able to communicate effectively.

Minimum Experience and Training Requirements: A bachelor's degree and one year relevant program experience.

Physical Requirements: Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)