Protocol Project Manager (Sr. CRC) - Gastrointestinal Oncology Program

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of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

Pre-Trial Activation

• Work with the research program director and PIs to identify potential studies and ensure a diverse research portfolio.
• Complete pre-activation tasks such as feasibility surveys and assessment with study team; lead pre-site selection teleconference calls
• Act as the main point of contact between the industry sponsor/collaborator and UCSF.
• Serve as Disease Site Committee Administrator and coordinate program site committee meeting per NCI and UCSF Protocol Review and Monitoring System (PRMS) standards for meeting conduct and documentation; coordinate protocol reviews and submissions to Disease Site Committee
• Determine, submit and/or communicate all ancillary committee requirements and approvals.
• Facilitate the completion of site questionnaires and communication between sponsors/collaborators and PI(s).
• Assist PI with the development of concept sheets, protocols, investigational brochure or package insert, and consent forms working in close collaboration with the Protocol Development team for investigator initiated trials.
• Collect and disseminate start up packet documentation from sponsor/collaborator to study team and trial activation teams in the CRSO regulatory unit
• Submit protocol package to the Protocol Review and Monitoring Committee (PRMC), Committee for Human Research (IRB/CHR) and/or any ancillary committees (i.e. BioSafety, radiation safety, etc.).
• Track all regulatory approvals and notify study team for trial status and proper training; prepare reports and trackers to keep the Disease Site Committee appraised of activation status for all new protocols
• Ensure protocol progression through the activation pipeline liaising between the sponsor/collaborator, study team and UCSF trial activation teams (regulatory affairs, budget, and contracts).
• Request and review trial activation team work for accuracy and completion for ICF drafting, CHR and FDA submission/approval, clinicaltrials.gov registration and NCT#, calendar build, coverage analysis and budget completion including pharmacy, nursing and/or central lab budget, contract execution, COA# and ZZ# from PostAward and billing mechanisms (APEX, HBS).
• Prepare and make submissions to IRBServe as point of contact for communication with the drug manufacturer as needed, including consent form approval and submission of committee review, approval information and CRSO unit needs.
• Consult with PI to determine which procedures are standard of care vs. research-related for coverage analysis and radiation safety form completion and submission.
• Assist PI with responses to protocol review, CHR and ancillary committees, and ensure timely response to stipulations, while proactively tracking and communicating approvals to study team, sponsors/collaborators and trial activation team(s).
• Provide the CRSO trial activation teams with the necessary documents to begin work such the sponsor’s protocol, investigator’s brochure or package insert, draft budget, CTA, and ICF template.
• Review and approve ICF language, MCA with calendar and budget.
  • Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiation teleconference calls

• Prepare and maintain regulatory binders; ensure that all regulatory documents (committee approvals, 1572, lab certifications, CVs, etc.) are sent and/or obtained from the sponsor/collaborator.

• Request creation of case report forms for investigator-initiated trials.

• Collaborate with ancillary departments to set up operational aspects of new studies (e.g. pharmacy, radiology, and labs)

• Follow up with Nurse Practitioner (NP) and/or CRC to ensure proper communication of required information and documentation (including MD/Infusion Orders, lab information, etc.).

• Schedule and conduct site initiation visits with PI, CRC, pharmacy, research RN and sponsor.

• Follow up with investigational pharmacy to ensure correct written orders and drug treatment supply.

• Interface with affiliates to ensure quick activation or affiliate (e.g., VAMC).

• For MCT ISTs (UCSF coordinating site), ensure that all participating centers are in compliance and are monitored regularly.

30

Study Maintenance

• Track and manage communication and procedures for all IRB-open studies at various stages, simultaneously; all within compliance standards.

• Forward all investigator-initiated modification requests to the protocol editors in a timely manner, and send all protocol amendments from industry sponsors to the regulatory affairs specialists, ITR Clinical Trials Budget Office and post-award analysts.

• Complete and submit updated renewal information for CHR renewals and IND annual reports to the regulatory affairs.

• Ensure that the electronic clinical trials management database(s) remain(s) current.

• Assess amendments after notification, process the amendment from protocol review through to budget amendment, and communicate changes to study team members/CRCs.

• Ensure appropriate correct ICF version is being used by CRCs, and the re-consenting of patients is/is not necessary.

• Notify industry sponsors/collaborators and study team as timelines change.

• Maintain up-to-date regulatory binder(s).

• Interface with Compliance team to ensure that clinicaltrials.gov is updated regularly and appropriately

• Schedule and lead weekly budget meetings with budget analyst.

• Prepare for audits and monitoring visits, and corresponding to any outstanding regulatory items.

• Ensure policies mandated by the UCSF IRB, HDFCCC, federal government, any outside entity, and study team are followed during trial activation pipeline, maintenance phase and close-out.
• Coordinate and prepare for sponsor or collaborator visits such as site initiation, audit, and monitor visits.
• Assist study team to develop contingency action plans.
• Lead trainings within the Disease Site Committee and HDFCCC
• Develop and write group specific SOPs and policies
• Ensure that all investigators maintain the proper credentials and maintain these records in central regulatory binder (e.g. medical licenses, CVs, GCP/HSP certifications, NCI CTEP registration, SIP accounts, etc.); serve as registration coordinator to help investigators maintain these varied accounts

5

Study Close-Out (Including Withdrawal)

• Ensure data and regulatory repositories are accurately updated, and regulatory paperwork is submitted for close-out, and properly archived; all teams are notified accordingly.
• Input final results data into clinicaltrial.gov within one year of the study completion date.

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