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

Medical University of South Carolina•Charleston, SC

12d•$66,400 - $119,500•Onsite

About The Position

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.

Requirements

A bachelor's degree and three years relevant program experience.
Must be a good communicator and must be knowledgeable in GCP, the Code of Federal Regulations (CFR), and clinical trial operations.

Responsibilities

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 clinicaltrials.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.
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 feasibility.
Creates and revises study documents and applications per investigator, study team, HCC Protocol Review Committee (PRC) and MUSC local IRB and FDA requirements.
Collaborates with investigational pharmacy, laboratory, and other ancillary services to develop manuals and edits to respective protocol sections.
Coordinates with Office of Research & Sponsored Program (ORSP) for contracts with external parties or vendors.
Responsible for the development and implementation of study specific data safety monitoring plans, which will be used throughout the life of the study to ensure reportable events are submitted to the HCC Data Safety Monitoring Committee (DSMC), IRB and FDA as required.
Coordinates and participates in team meetings with investigators and support staff as indicated to focus on the development and activation of the IIT, which may include external collaborators and sub-sites.
Takes ownership of communicating action items and following up with stakeholders for completion according to project timelines.
Must be a good communicator and must be knowledgeable in GCP, the Code of Federal Regulations (CFR), and clinical trial operations.
Follows the CTO task lists for study activation and participates with timely updates within internal CTO meetings to report on the activation statuses.
Maintains and manages electronic study files during study activation for IITs.
Leads hand-off of study to SISU maintenance team after study activation.
Supports activation activities of single patient investigational new drug (IND) applications.
During study start-up, receive amendment requests from study collaborators and investigators to process protocol and/or regulatory amendments.
Track these changes within the development of new protocol, informed consent, summary of changes, or other IRB approved materials, with proper version control and effective release date.
Submit changes to the IRB or record and FDA application as applicable.
Manages version control of documents and ensures harmonization of all versions across reviewing committees prior to activation.
Supports major protocol amendment writing for studies open to enrollment on an as needed basis.
Administrative Support of HART and any concept development meeting that includes taking minutes, scheduling meetings, revising documents, and preparing and presenting agenda items.
Supports SISU Administrative Director in implementing HART program initiatives and adapts effectively to evolving workflows, process improvements, and shifting organizational priorities.
Provide project management of special activities.