UNIV - Program Manager I - Medicine: Gastroenterology

Apply now Job no: 505602
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: Manager/Supervisor, Research, Clinical Trials, Grants Administration
Pay scale: UNIV-Band 7: $48,622.00 - $69,289.00 - $89,956.00 (min - mid - max)

Job Duties:
10Research 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, checks all EPIC charges and assigns them to the appropriate billing buckets. Review medical records and confirms patient charges to include confirming standard of care vs. research charges, and ongoing follow up to ensure appropriate patient billing compliance.Essential
15Contract and Budget Development. Works with Grants and Finance Office to develop study contracts and budgets to ensure financial viability while ensuring adherence to protocol regulations. Ensures adequate resources of personnel and equipment are readily available for successful implementation of studies. Develop/ negotiate budgets based on anticipated enrollment and PI/coordinator effort requirements. Monitors funds expenditures and balances in all active studies through UMS.Essential
15Grant Submissions and Administration: Builds the infrastructure needed for growth of clinical trials and other programs including procurement of supplies and equipment as needed. Fulfills all pre and post award requirements, including provides training, mentorship and guidance to other research staff on the pre and post award process. In collaboration with the PI, develops research plans, utilizing research methodology knowledge. Oversees, develops and monitors budget reports, project revenue and expenditures and other post award activities. Completes study tracker for timely invoicing.Essential
15Regulatory Affairs and Quality Assurance: Acts as regulatory authority and advisor training and educating employees, faculty and advising research team. Manages multisite regulatory documents. Works closely with the IRB and IBC when creating complex clinical trial submissions. Meet with the IRB and IBC to plan for acquisition of study approval and submit reports. Assures studies are carried out according to code and MUSC policies. Manages site readiness and close-out activities, conduct site initiation and writes reports and develops corrective action plans. Identifies data discrepancies and protocol non-adherence issues, generates and reconciles queries, retrain staff as needed.Essential
30Provides direct on-site supervision of approximately 5 research staff to ensure the appropriate conduct of studies at all sites. Supervises and evaluates research staff working on 16 research studies. Allocates personnel resources to accommodate demand for all studies. Provides strategic input regarding study activities to PI. Develops Standard Operating Procedures, documents the lab processes along with handling the procedures for the freezer and freezer log. 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 and policies. Manage personnel needs, assisting other coordinators with billing, IRB submissions and SPARC submissions. Performs random audits of regulatory materials to ensure proper documentation and adherence to study protocols.Essential
5Clinical Trial Coordination: Develops and maintain multiple REDCap databases used for clinical trials reporting, grant submissions, enrollment updates, screen fail recording, and for institutional support.Essential
5Reporting. Serves as PI representative for each study and multi-site trial in direct communications with the MUSC IRB, Western IRB (WIRB), and the Biosafety Committee. Oversees annual audits conducted by these entities. Conducts regular meetings with all site PIs to ensure adherence to research protocols and to provide financial progress reports. Reviews recruitment reports to assess effectiveness of recruitment strategies and implement changes when necessary by allocating resources appropriately. Applies protocols and institutional guidelines to differentiating adverse vs. serious adverse events following appropriate reporting guidelines. Documents adverse and serious adverse event. Ensures PI reviews and appropriately documents assessment and intervention.Essential
5Special projects and other duties as assigned.Essential

Job summary: Position is responsible for overseeing the research projects for one Principal Investigator (PI). This position requires the direct supervision of study staff to ensure the appropriate conduct of all studies. This individual will consult directly and independently with Principal Investigators at all outside participating institutions. Other responsibilities included creation and negotiation of budgets and contracts with outside funding entities, and fulfillment of all reporting and regulatory requirements for MUSC IRB, Central IRBs, and Biosafety Committee.

Payscale Salary Range: UNIV-Band 7: $48,622.00 - $69,289.00 - $89,956.00 (min - mid - max)

FLSA: Salaried

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

Preferred Qualifications: In addition to prior experience managing multiple trials, advanced educational background in the biological sciences is required to facilitate development of investigator initiated protocols and grant funding applications. Experience with development and use of complex databases and knowledge of Medicare billing is preferred

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 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 20/20 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 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)

Opening date: Eastern Daylight Time
Applications close: 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.