Protocol Project Manager - Thoracic Oncology Research Program

University of California - San Francisco Campus and Health; San Francisco (CA); On-site; USD 150,000 - 200,000; Full time

Job summary

An established industry player is seeking a Protocol Project Manager for their Thoracic Oncology Research Program. This pivotal role involves coordinating clinical trials, managing relationships with study teams and external entities, and ensuring compliance with regulations. The ideal candidate thrives in a dynamic environment, possesses strong project management skills, and excels in communication. Join a team dedicated to advancing cancer research and improving patient outcomes in a supportive and innovative setting. This position offers a unique opportunity to contribute to groundbreaking work in oncology while enjoying a competitive salary and comprehensive benefits package.

Benefits

Health Insurance

Retirement Plan

Paid Time Off

Flexible Work Hours

Professional Development Opportunities

Qualifications

• Bachelor's degree in related area and sufficient experience.
• Demonstrated ability to develop recruitment strategies.
• In-depth knowledge of clinical research contracts and FDA regulations.

Responsibilities

• Coordinate protocol reviews and submissions to committees.
• Ensure timely processing of new protocols through activation pipeline.
• Study coordination and data collection for multiple studies.

Skills

Project Management

Clinical Trials Knowledge

Analytical Skills

Interpersonal Communication

Recruitment Strategies

Problem Solving

Organizational Skills

Adaptability

Education

Bachelor's Degree in Related Area

Tools

Microsoft Office

Clinical Trials Management Software

Job description

Protocol Project Manager - Thoracic Oncology Research Program

HDF Comprehensive Cancer Center

Full Time

84826BR

Job Summary

The Protocol Project Manager (PPM) will work in the Thoracic 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.

Note: This position requires a physical/health screening

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

Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

The salary range for this position is $41.72 - $67.10 (Hourly Rate).

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) 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.

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 is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

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

San Francisco, CA

Campus

Mission Bay (SF)

Work Style

Fully On-Site

Shift

Days

Shift Length

8 Hours

Additional Shift Details

Monday - Friday