UNIV - Clinical Research Assistant (Regulatory) - Department of Medicine: Division of Pulmonary

Job Duties: 35% - Responsible for meticulous and careful management of regulatory documentation of the Program’s regulatory files; maintains up-to-date files of CVs, medical licensure, note-to-files, conflict of interests, training documentation, laboratory certifications and other documents as needed. Ensures regulatory documents are updated in a timely manner and available for the site monitor at all times. 35% - Build electronic regulatory binders. Alert staff of new documents that are available and ensure documents are filed. Route and track completion of documents requiring signature. Will be responsible for preparing regulatory files for on-site monitoring visits, sponsor audits and regulatory authority audits, as well as reconciling and resolving action items following said on-site visits. 15% - Assist with the following as needed: scheduling and setting up monitoring visits and access for monitors; complete annual continuing reviews on all open studies. 10% - Perform other duties as required. Assist with Source Database building in Redcap. 5% - Provide general office support as needed.

Additional Job DescriptionMinimum Requirements: A high school diploma and three years of relevant program experience. A bachelor's degree may be substituted for the required program experience.

Physical Requirements: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift 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. (Continuous) 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 20/40 vision, corrected, in one eye or with both eyes. (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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent) The Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. There are career opportunities available in academics, research, hospital medicine, physician practices and support services, from patient billing to IT. As an applicant, you can search jobs for all MUSC entities as well as search by category and location. MUSC attracts more than $250 million annually in research funding, making it the biggest magnet for biomedical, extramural research dollars of all institutions of higher learning in South Carolina. The Clinical and Translational Science Award (CTSA) Program aims to advance clinical and translational science to increase the speed at which new treatments become available to patients. MUSC Health, the clinical enterprise, operates a 750 bed medical center, which includes a nationally recognized Children’s Hospital, the Ashley River Tower (cardiovascular, digestive disease, and surgical oncology), Hollings Cancer Center (one of fewer than 70 elite National Cancer Institute designated centers), a Level I Trauma Center and the Institute of Psychiatry. In addition, there are more than 100 outreach clinics, hospital/health system affiliations, and telehealth sites. U.S. News & World Report placed us among the top one percent of all American hospitals, with 11 specialties in the top 50. The MUSC Medical Center is also one of only three Magnet designated hospitals in South Carolina.