UNIV - SISU Start-Up Manager & Protocol Writer - Hollings Cancer Center

MUSC Health; Charleston (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

MUSC Health seeks a Regulatory Specialist to oversee the pipeline and activation of investigator‑initiated oncology trials at Hollings Cancer Center. Working with the SISU Administrative Director and the HART Scientific Director, you will coordinate study start‑up, regulatory documents, and submissions to ensure GCP compliance across participating locations.

This role requires a bachelor’s degree and three years of relevant program experience, strong regulatory knowledge, and proven

Qualifications

• Bachelor’s degree and three years of relevant program experience.
• Experience with regulatory submissions to FDA/IRB and GCP guidelines preferred.
• Knowledge of regulatory requirements for investigator-initiated oncology trials.

Responsibilities

• 35% HCC Investigator Trial Concept Support: manage intake, prioritize submissions, coordinate concept meetings, and maintain status communication in OnCore.
• 35% IIT Activation: complete FDA/IRB applications, coordinate responses, develop study documents, and support IND activation with stakeholders.
• 20% IIT Amendments: process amendments, track changes, manage version control, and assist with protocol amendments.
• 10% Administrative Support: minutes, scheduling, document revision, and project management of HART initiatives.

Skills

Regulatory Compliance

FDA Submissions

IRB Coordination

Study Documentation

OnCore

Project Management

Education

Bachelor's Degree

Tools

OnCore

Job description

Job Description Summary

Under the guidance of the Sponsor‑Investigator Support Unit (SISU) Administrative Director and the Scientific Director of the Hollings Advisory for Rapid Translation (HART), this individual will work closely to oversee pipeline and activation of an assigned portfolio of MUSC investigator‑initiated oncology clinical trials.

Job Description

Under the guidance of the Sponsor‑Investigator Support Unit (SISU) Administrative Director and the Scientific Director of HART, the incumbent will conduct administrative duties associated with the Sponsor‑Investigator responsibilities of HCC IITs, including study operational and regulatory document development and coordination; study start‑up project management; and study regulatory submissions. The purpose of this role is to ensure that Hollings Cancer Center (HCC) Investigator Initiated Trials (IITs) are prepared and implemented according to Good Clinical Practice (GCP) guidelines and federal, state, and local requirements at all participating locations.

Responsibilities

35% HCC Investigator Trial Concept Support

Provides support to the SISU Administrative Director and HART leadership in managing the intake of new MUSC investigator oncology trial concepts, prioritizing submissions, administering concept meetings, consulting with investigators and other stakeholders, supporting protocol development, drafting study documents, and maintaining accurate status communication in OnCore. Escalates delays and supports corrective action initiatives.

35% HCC Investigator‑Initiated Trial (IIT) Activation

Serves as the regulatory specialist to complete FDA and Institutional Review Board (IRB) applications; coordinates responses; ensures protocol follows standard CTO activation process; develops study documents and applications; collaborates with pharmacy, laboratory, and ancillary services; manages data safety monitoring plans; and supports activation activities, including IND applications.

20% HCC IIT Amendments

Processes amendment requests during study start‑up, tracks changes, submits them to IRB or FDA as required, manages version control, and supports major protocol amendment writing on an as‑needed basis.

10% Administrative Support

Assists with meeting minutes, scheduling, document revision, agenda preparation, and implementation of HART program initiatives. Provides project management of special activities and adapts to evolving workflows.

Additional Job Description

Minimum Requirements: A bachelor’s degree and three years of relevant program experience.
Physical Requirements: Ability to perform job functions in upright, seated, and walking positions, complete repetitive motions, reach in all directions, maintain vision and hearing acuity, lift up to 15 lbs., and work in various environments as described.

Equal Opportunity Employment

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.