UNIV - Clinical Research Assistant - Surgery: Clinical Trials

UNIV
- Clinical Research Assistant
- Surgery:
Clinical Trials

The Department of Surgery, Division of Transplant Surgery Research is actively recruiting for a Clinical Research Assistant. The Clinical Research Assistant is responsible for coordination of investigator-initiated transplant studies for the Department of Surgery as directed by the Principal Investigator. This person will also conduct all research in adherence with the FDA Code of Federal Regulations, "Good Clinical Practices", and adhere to the MUSC IRB regulations for the protection of human subjects.

Location:

Charleston, South Carolina

Job Duties:

• 35% - The Program Assistant will ensure study-required clinical elements and tests are conducted and collected according to the protocol. They will conduct simple study visits per study protocol.
• 25% - The Program Assistant will obtain and document informed consent under the direction of the Principal Investigator. They will maintain accurate informed consent documents for later review.
• 20% - The Program Assistant will screen and prescreen potential patients for their assigned research studies. They will maintain screening and enrollment logs, as required, and provide periodic updates to the study team.
• 10% - The Program Assistant will complete case reports forms and other source documents in a timely manner. They will create simple data collection forms, when required, to capture protocol specific data.
• 10% - The Program Assistant will perform simple data entry to study databases in a timely manner. They will be responsible for the resolution of study specific queries within the EDC system.

Preferred

Education and Experience:

A bachelor's degree. Works independently with minimal supervision. Must exercise judgment and discretion. Establish and maintain effective working relationships. Must be able to communicate effectively.

Minimum Requirements:

A high school diploma and four years of relevant program experience. A bachelor's degree may be substituted for the required program experience.

Physical Requirements:

Ability to perform job functions in an upright position, seated position, while walking/mobile, indoors, outdoors in all weather and temperature extremes, in confined/cramped spaces, from kneeling positions, squat and perform 'pinching' operations, use both hands/arms, perform repetitive motions with hands/wrists/elbows/shoulders, reach in all directions, maintain tactile sensory functions, lift and carry 15 lbs., unassisted, push/pull objects, up to 15 lbs., unassisted, maintain 20/40 vision, corrected, in one eye or with both eyes, see and recognize objects close at hand, at a distance, determine distance/relationship between objects;

depth perception, good peripheral vision capabilities, maintain hearing acuity, with correction, hear and/or understand whispered conversations at a distance of 3 feet, perform gross motor functions with frequent fine motor movements, work in dusty areas.