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

Job Description

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.

Qualifications

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)