UNIV - Program Manager I - Department of Medicine: Division of Pulmonary

Job Description Summary

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Job Description

Job Duties:

25% - Financial Management: Develops study contracts and budgets to ensure financial viability while ensuring adherence to protocol regulations, proper allocation of resources for personnel and diagnostic testing. Develop/ negotiate budgets based on projected enrollment and PI/coordinator effort requirements. Manages funds on a daily basis including PEARs for staff as well as monitoring funds expenditures and balances in all active studies. Runs financial reports along with progress reports for studies to determine the need and feasibility of staffing needs.

20% - Program Development and Staffing: Provides direct on-site supervision of MUSC-based and participating-site study staff to ensure the appropriate conduct of studies at all sites. Supervises and evaluates research staff working on current research studies. Allocates personnel resources to accommodate demand for all studies. Educates and in-services fellows, physicians, hospital staff and study staff regarding research requirements. Provides strategic input regarding study activities to PI. Develops Standard Operating Procedures, writes out the lab processes along with handling the procedures for the freezer and freezer log in File Maker. Provides training to other staff on informed consent and HIPAA. Acts as liaison between sponsor, PI and ancillary services. Mentors clinical research team on research related tasks and trains in federal and local federal regulations.

 20% - Grant Submissions and Administration: Builds the infrastructure needed for growth of clinical trials and other programs including procurement of supplies and equipment as needed. Fulfills pre- and post-award requirements of research studies. Provides training, mentorship and guidance to other research staff on the pre and post-award process. Develops research plans and works with sponsor and PI to develop and modify study protocols. Oversees develops and monitors budget reports, project revenue and expenditures and other post-award activities. Generates invoices based on study enrollment.

15% - Regulatory Affairs and Quality Assurance: Acts to educate research team on regulatory affairs.

Manages multi-site regulatory documents. Works closely with the IRB and IBC when creating complex clinical trial submissions such as gene therapy. Meets with the IRB and IBC to plan study approval and submit reports. Assures studies are carried out according to MUSC policies. Organizes site initiation visits with sponsors and manages site readiness and close-out activities.

10% - Research Billing and Compliance: Oversees all aspects of the research billing process and trains  essential personnel on billing compliance. Responsible for ensuring study participant charges are accurate. Review medical records and confirms patient charges for standard of care are accurately billed.

5% - Communicates with the MUSC IRB, Western IRB (WIRB), and the Biosafety Committee. Prepares for audits conducted by these entities. Conducts regular meetings with research coordinators to assure adherence to answering queries.

5% - Other duties as assigned.

Additional Job Description

Minimum Requirements: A bachelor's degree and three years relevant program experience.

Physical Requirements: (Note: The following descriptions are applicable to this section: 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. (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 lift objects, up to 15 lbs., from floor level to height of 36 inches, 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 match or discriminate between colors. (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)

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

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.

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