UNIV - Program Coordinator I - Department of Medicine: Division of Pulmonary
About The Position
Program Coordinator will provide technical and clinical support for research studies with the Division of Pulmonary and Critical Care for the Department of Medicine. 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. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees.
Requirements
- A bachelor's degree
- Two years of relevant program experience.
Responsibilities
- Management of subject recruitment and enrollment to assigned research studies, including creating and adapting recruitment and advertising materials, recruitment tracking, and independently screening subjects.
- Review patient medical records to identify subjects who qualify for actively enrolling studies.
- Independently consent subjects for assigned studies in adherence to human subjects’ protection regulations.
- Schedule study visits and conduct assessments of study procedures per study protocol.
- Preparation, collection, processing, and shipment of biological research specimens.
- Assist with management of investigational products and coordination of the IP with investigational pharmacies.
- Coordinate the reporting of adverse events to appropriate entity.
- Routine and complex data collection and data entry as well as query resolution.
- Maintain current and long-term follow-up data on all assigned study subjects.
- Creation, development, and management of simple online databases (MUSC RedCap, etc).
- Creation of complex data collection forms (CRFs and source documents) according to the study protocol.
- Regulatory management of assigned research studies, including maintaining regulatory and training documents as required by Federal, State, local, Institutional and protocol regulations and policies.
- Maintain accurate study registration on (Clinicaltrial.gov, etc.).
- Serve as primary liaison with the IRB for assigned studies and be responsible for initial study application submission, continuing reviews, amendments, and protocol deviations.
- Directly interact with site personnel and principal investigators, including those at remote sites participating in multi-site trials or tele-medicine programs, requiring effective communication skills, both written and verbal.
- Participate in team meetings and provide study updates as required.
- Communicate and coordinate with other research personnel as required for study implementation and routine problem resolution.
- Regularly review study financial records to ensure accurate billing and resources assigned to each study.
- Prepare for study monitoring visits and audits and assist with addressing findings.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
