Oncology Trial Start-Up Lead & Protocol Writer

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

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