The Protocol Project Manager (PPM) will work within the GI Oncology program and serve as the main point of contact between the study team including faculty and clinical research coordinators (CRC), outside entities such as sponsors, and various departments within UCSF providing support. The candidate will be accountable for clinical trial study start up, maintenance, and close out. A successful applicant will thrive in a fast-paced environment, take initiative, and resolve problems and provide clarity in ambiguous situations. We are looking for a go-getter with excellent relationship building skills, and a team player who can also work independently.
Duties Include:
- Complete pre-activation tasks such as feasibility surveys and assessment with study team; lead pre-site selection teleconference calls
- Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review and Monitoring Committee
- Serve as Disease Site Committee Administrator, set agendas, and lead meetings in close collaboration with the Site Committee Chair
- Identify ancillary committee approval with study team required by a protocol and initiate the process for review; complete various applications to ancillary committees such as radiation safety and biosafety applications.
- 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. Ensure timely processing of new protocols through the activation pipeline including Medicare coverage analysis and budget sign off, informed consent approval and IRB submission, contract execution, and billing set up; prepare reports and trackers to keep the Disease Site Committee appraised of activation status for all new protocols
- Review, provide feedback, and approve Medicare coverage analysis and budgets for complex clinical trials; serve as point person from study team for budget negotiations
- Prepare and make submissions to IRB; prepare and maintain regulatory binders
- Collaborate with ancillary departments to set up operational aspects of new studies (e.g. pharmacy, radiology, and labs)
- 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.
- Update clinical trial management databases.
- 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
- Flexibility to adapt to changing circumstances.
- Excellent organizational skills, multitasking and communication both written and spoken.
Department Overview:
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI). The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.
% of time Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
15YesPre-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.
40YesTrial Activation 30 YesStudy 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 YesStudy 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.
10 YesOther Duties as assigned 100%
Required Qualifications
- BS/BA Degree in a related area; or equivalent experience
- Project management or coordinator experience
- Experience with clinical trials regulatory affairs, or related clinical trials experience such clinical research coordinator experience
- Working knowledge of clinical trial design, clinical study operations, or regulatory approval process
- Demonstrated ability to work within a team environment with faculty and staff at all levels
- Working knowledge of Microsoft Office applications such as Word, PowerPoint, Project and Excel
- Experience working with medical providers and personnel
- Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire
Preferred Qualifications:
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- Experience with oncology clinical trials, or related therapies in drug clinical trials
- Exposure to, or on the job use of, medical terminology
- Experience preparing submissions for IRB, IND safety reporting, or continuing reviews
- Experience with clinical trials management software such as OnCore
- Licensure for management, healthcare and/or clinical trials coordination (i.e. PMP, CCRP, SoCRA)