Oncology IIT Start-Up & Protocol Lead

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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. 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.

This individual will conduct administrative duties associated with the Sponsor-Investigator responsibilities of HCC IITs, including but not limited to study operational and regulatory document development and coordination; study start-up project management; and study regulatory submissions.

Responsibilities
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35% HCC investigator Trial Concept Support
Provides support to the SISU Administrative Director and the Scientific Director of HART in managing the intake of new MUSC investigator oncology trial concepts. Works with SISU Administrative Director and HART leadership to prioritize submissions based on established criteria per institutional and National Cancer Institution (NCI) guidelines. Administers monthly and ad hoc concept meetings for the active monitoring of timely progress of concept review and development from intake until abandonment or trial activation.

Consults with principal and co-investigators, biostatisticians, translational lab scientists, and leaders of HART to supporting the growth of the HCC IIT pipeline. Utilizes approved tools for trial development. Searches clinical trials.gov trial listings and reviews other past trial documents to support the protocol writing of new HCC IIT protocols. Supports the drafting and editing of the protocol, informed consent, and other study specific documents such as but not limited to patient questionnaires, drug diaries, and trial summaries.

Reviews Investigator Brochures (IB) and package inserts to help draft drug administration, risk profile, and safety assessment language. Drafts study calendar and activities of a protocol document. Utilizes the appropriate model documents for protocol documents, informed consent, regulatory and patient data collection instruments to support the rapid activation of new IITs. Organizes collaborative meetings and follows HCC policies regarding new trial intake and document management, including rules of study entry and task list reporting in the OnCore clinical trials management system.

Must have strong project management and team communication skills to ensure that the HCC IIT pipeline expands and grows per HCC strategic goals. Responsible for recording study status updates, managing staff listings, and uploading up-to-date documents, in a detailed, accurate and timely manner within the appropriate Clinical Trials Office (CTO) systems (e.g. OnCore, eReg, etc.). Ensures accurate status communication of trial concepts and activation milestones within Pending Projects meeting and other reporting requests.

Escalates delays in a professional and timely manner and supports corrective action initiatives.

35% HCC Investigator-Initiated Trial (IIT) Activation
Serves as the regulatory specialist to complete Food and Drug Administration (FDA) and Institutional Review Board (IRB) applications, and coordinates responses back to these regulatory bodies during the review process. Works very closely with the PI, HCC Data Science Shared Resource, CTO study team and other relevant stakeholders in the development and activation process of new HCC IITs. Ensures that each protocol follows standard CTO activation process with assurance that the IIT is vetted by the clinical program managers ancillary providers, and SISU Administrative Director for operational and financial…