Protocol Project Manager

Protocol Project Manager - Pediatric Oncology

HDF Comprehensive Cancer Center

Full Time

77624BR

Job Summary

The Protocol Project Manager (PPM) will work in the Pediatric Oncology 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 (CRSO), 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, and may assist with study operations, including participant management and data entry, as required.

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 and Monitoring 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 CRSO 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.
• Study coordination and data collection for multiple studies within the program's portfolio.
• Assist study team to develop contingency action plans.
• Flexibility to adapt to changing circumstances.
• Excellent organizational skills, multitasking and communication both written and spoken.

The final salary and offer components are subject to additional approvals based on UC policy.

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 (https : / / tcs.

ucop.edu / non-academic-titles)

Please note : 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

Department Description

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) holds the prestigious designation of "comprehensive" from the National Cancer Institute (NCI).

We combine basic science, clinical research, epidemiology, cancer control and patient care throughout UCSF.

Required Qualifications

• Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and / or equivalent experience / training.
• 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.
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Working knowledge of Microsoft Office applications such Required as Word, PowerPoint, Project and Excel.
• Experience with clinical trials regulatory affairs, or related clinical trials experience such as clinical research coordinator experience.
• Demonstrated ability to work within a team environment with faculty and staff at all levels.
• Experience working with medical providers and personnel.

Preferred Qualifications

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
• 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).

License / Certification

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.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health.

We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care.

Additional information about UCSF is available at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California San Francisco is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Organization

Campus

Job Code and Payroll Title

007889 CLIN RSCH CRD SR NEX

Job Category

Research and Scientific, Supervisory / Management

Bargaining Unit

University Professional Technical Employees - Research Support Professionals Unit (UPTE-RX)

Employee Class

Career

Percentage

100%

Location

Mission Bay (SF)

Shift

Days

Shift Length

8 Hours

Additional Shift Details

Mon-Fri; 8 hours / day