Full TimeDays8 Hours Mon-Fri; 8 hours/dayThe Protocol Project Manager (PPM) will work in the Early Phase Investigational Therapeutics research 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 the Clinical Research Support Office, which is a centralized service unit in the HDFCCC offering clinical trial management services. 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.
• Coordinate protocol reviews and submissions to Disease Site Committee and Protocol Review Committee.
• Identify ancillary committee approval with study team required by a protocol and initiate the process for review.
• Assist PI with the development of concept sheets, investigational brochure or package insert for ITR regulatory protocol editor 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.
• Ensure policies mandated by the 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.
• Flexibility to adapt to changing circumstances.
• Excellent organizational skills, multitasking and communication both written and spoken.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (ucop.edu)

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% - 120% of the established mid-point. An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

· 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. · HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities. · Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals. · In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures. · Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects. · Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills. · Ability to analyze complex and non-routine issues requiring innovative solutions. · Ability to operate effectively in a changing organizational and technological environment. · Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines. · Ability to interpret and apply policies and regulations. · Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets. · Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities. · Experience using database software, such as MS Access or FileMaker Pro.

• BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
• 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. (Required)

• 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. (Required)