Medical University of South Carolina UNIV - Research Coordinator II - Department of Medicine: Gastroenterology in Charleston, South Carolina
Job Summary: This position is for a senior clinical research coordinator who is capable of performing the full range of study-related duties in the Department of Gastroenterology (with a potential focus on Inflammatory Bowel Disease). The Program Coordinator II will report to the Gastroenterology department and work directly with research investigators to manage and implement a number of pharmaceutically-sponsored clinical research trials. This position will be responsible for adhering to study guidelines, coordinating and performing study visits, maintaining regulatory documents, and providing education to patients and their families.
30% - Maintain all study documents and regulatory status as required by regulatory authorities and study sponsors. Create and review source documents templates. Ensure (1) study documents and regulatory documents are complete, organized and readily available for audits; (2) study patients complete all protocol requirements within designated timeframes; (3) study data is accurate and timely; (4) all study activities are performed in compliance with federal regulations and institutional IRB policies; (5) proper communications with study sponsors, study monitors, and regulatory agencies; (6) maintain appropriate certifications and credentials. (Essential) - (Essential)
25% - Coordinate study on a daily basis with all necessary study personnel, including research nurses, lab technicians, MUSC grants and contracts, and pharmacy staffs. Prioritize patient safety. Educates study personnel on protocol changes. Provides additional education, training, and follow-up to personnel and subject/caregiver where necessary and appropriate. (Essential) - (Essential)
25% - Serve as the lead study coordinator in clinical trials. Act as the local point of contact from study conception to close-out. Obtain informed consent, screen and enroll study participants per study inclusion and exclusion criteria to meet study contract enrollment, 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. - (Essential)
10% - Facilitate study start-up logistics. (Essential) - (Essential)
5% - Evaluate the effectiveness of research services based upon program objectives and determines ways to improve internal coordination of research and clinical work flow. Reviews and analyzes reports. - (Essential)
5% - Other research-related duties assigned by the program leadership. - (Essential)
Minimum Experience and Training Requirements: A bachelor's degree and two years 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)