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

Responsibilities

• HCC investigator Trial Concept Support
• Supports intake of new MUSC investigator oncology trial concepts.
• Prioritizes submissions based on institutional and NCI guidelines.
• Administers monthly and ad hoc concept meetings for timely progress monitoring.
• Consults with principal and co-investigators, biostatisticians, translational lab scientists, and HART leadership.
• Utilizes approved tools for trial development.
• Searched clinicaltrials.gov and reviews past trial documents to support protocol writing.
• Supports the drafting and editing of protocol, informed consent, and other study-specific documents.
• Reviews Investigator Brochures (IB) and package inserts for drug administration, risk profile, and safety assessment language.
• Drafts study calendars and activities of a protocol document.
• Uses appropriate model documents for protocol documents, informed consent, regulatory, and patient data collection instruments.
• Organizes collaborative meetings and follows HCC policies regarding new trial intake and document management.
• Records study status updates, manages staff listings, and uploads up-to-date documents within CTO systems.
• Ensures accurate status communication and escalates delays professionally and promptly.
• HCC Investigator-Initiated Trial (IIT) Activation
• Completes FDA and IRB applications and coordinates responses during the review process.
• Collaborates with PI, HCC Data Science Shared Resource, CTO study team, and other stakeholders.
• Ensures protocols follow standard CTO activation process and are vetted by clinical program managers, ancillary providers, and SISU Administrative Director.
• Develops and revises study documents and applications per investigator, study team, HCC PRC, and MUSC local IRB and FDA requirements.
• Collaborates with investigational pharmacy, laboratory, and ancillary services to develop manuals and edit protocol sections.
• Coordinates with ORSP for contracts with external parties or vendors.
• Develops and implements study-specific data safety monitoring plans.
• Coordinates and participates in team meetings with investigators and support staff.
• Takes ownership of communicating action items and follows up with stakeholders for completion according to project timelines.
• HCC IIT Amendments
• Receives amendment requests from study collaborators and investigators to process protocol and/or regulatory amendments.
• Tracks changes within the development of new protocol, informed consent, summary of changes, or other IRB-approved materials.
• Submits changes to IRB or records and FDA applications as applicable.
• Supports major protocol amendment writing for studies open to enrollment on an as-needed basis.
• Administrative Support of HART and Concept Development Meetings
• Takes minutes, schedules meetings, revises documents, and prepares and presents agenda items.
• Supports SISU Administrative Director in implementing HART program initiatives.
• Adapts to evolving workflows, process improvements, and shifting organizational priorities.

Qualifications

• A bachelor's degree and three years relevant program experience.