UNIV - Program Coordinator I - Medicine: Gastroenterology

Apply now Job no: 502372
Entity: MUSC University
Department: COLLEGE OF MEDICINE - COM-Dept of Medicine
Sub Department: UNIV-2220300-Gastroenterology
Work type: Full-Time
Employee Type: UNIV - Research Grant
Location: Charleston, SC-Main Campus
Categories: Research
Pay scale: UNIV-Band 5: $32,838.00 - $46,799.00 - $60,760.00 (min - mid - max)

Job Duties:
10Prepare for and conduct monitor and auditor visits for each study as required by sponsor, FDA, or internal audit.Essential
15Collect and process lab samples that require specific training.Essential
15Coordinate proper data management according to protocol requirements and compliance, i.e. collect and record all data pertaining to study patients on specific study and submit on time to research bases. Provide database support (design, implement, update and review for integrity).Essential
20Assist with recruitment of research study patients on an on-going basis.Essential
35Serve as study coordinator in gastroenterology & hepatology clinical trials: Obtain informed consent, screen and enroll study patients, conduct study visits as per protocol, coordinate patient visits, provide education to subjects, monitor adverse events and prepare serious adverse event reports, collect and process lab samples, dispense study medication to patients, conduct patient diary reviews, enter data and complete case report forms, and maintain all study documents.Essential
5Travel to sponsor initiated investigator meetings with investigator to review protocols for initiation and to review clinical findings during trials.Essential

Job summary: The Department of Medicine's Division of Gastroenterology & Hepatology is seeking a candidate who under the direct supervision of Dr. Don Rockey, the research program coordinator will actively coordinate all aspects of research programs in the Division of Gastroenterology & Hepatology. Responsibilities will include: Interfacing with the Institutional Review Board to facilitate initial and maintenance of regulatory approval and to ensure research conduct of the highest regulatory standards including writing consent forms, notification and serious adverse events and protocol deviations to the IRB and sponsor. Coordination of corporate sponsored research studies, including: start up, execution of protocols, subject recruitment and enrollment, reviewing consent forms with subjects, conducting study visits, obtaining vital signs from patients, reviewing concomitant medications and adverse events with subjects, completion of case report forms and maintaining drug logs. Serve as a liaison with research sponsor representatives, maintain regulatory compliance and provide timely reports to program manager and principal investigator as to research trial status. Performing miscellaneous study-related research tasks (e.g., biospecimen acquisition & processing). Providing data management support to the investigator. Providing comprehensive research administrative support to the investigator. 

General guidelines: The candidate must meet the physical requirements and standards of behavior set forth by the Medical University of South Carolina.

Supervision: This position is expected to exercise professional judgement and discretion under limited supervision.

Payscale Salary Range: UNIV-Band 5: $32,838.00 - $46,799.00 - $60,760.00 (min - mid - max)

FLSA: To Be Determined

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

Additional Knowledge, Skills, and Abilities: Basic computer skills including Microsoft Office. Ability to coordinate the filing and electronic submission of research documents, and to track research study benchmarks. Basic clinical knowledge and technical abilities. One year or more experience as a research technician or medical assistant is strongly encouraged. The candidate should have a basic knowledge of research administrative processes, including regulatory documentation and research study logistics, and must be able to work on multiple projects in parallel. Some travel is required.

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)

Opening date: Eastern Daylight Time
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Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.