Clinical Research Supervisor/Protocol Project Manager
Helen Diller Family Comprehensive Cancer Center (HDFCCC) Job Summary The HDFCCC is seeking a Clinical Research Supervisor/Protocol Project Manager for the Pediatric Oncology Program. Under the supervision of the Clinical Research Manager, the Clinical Research Supervisor/Protocol Project Manager is tasked with managing and facilitating the Pediatric Oncology Program day-to-day operations of their direct reports including training and supervising a team of 3 - 6 clinical research coordinators and/or assistant clinical research coordinators. The Clinical Research Supervisor/Protocol Project Manager is responsible for training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, and implementation of protocols within the program that meet federal, state and institutional policies and guidelines.
The Clinical Research Supervisor/Protocol Project Manager assists the Clinical Research Manager in resolving operational, workload, protocol implementation, and data collection issues. The candidate will be a proven team-player with project management skills and mindset and have the ability to consistently deliver results on a tight timeline. The Clinical Research Supervisor/Protocol Project Manager will work with the Clinical Research Manager to develop standard operating procedures, and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice, with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity. The incumbent will be a team player and assist with projects, patient coverage, and other CRC duties whenever necessary.
In addition to supervising clinical research coordinators, along with the Principal Investigator and Sponsor, the Clinical Research Supervisor/Protocol Project Manager will serve as the main point of contact between Principal Investigators and Sponsors during study activation and maintenance. Specific duties related to study activation may include: completing pre-activation tasks such as feasibility surveys and assessment with study team; coordinating protocol reviews and submissions to Disease Site Committee and Protocol Review Committee; identifying ancillary committee approval with study team required by a protocol and initiate the process for review; and 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.
Other duties may include, but will not be limited to: facilitate start-up and study coordination at external sites for multi-site investigator-initiated studies; supporting the management and coordinating the tasks of single or multiple clinical research studies; coordinating study start-up; act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; train CRCs, oversee study data integrity and perform other duties as assigned. 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 $86,300 - $130,900 (Annual 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.
- Clinical Trial Professional certification from a professional society within one year in the position.
- At least 2 years' experience with industry clinical trials as a CRC.
- Supervisory experience or demonstrated experience in training others, particularly in the field of research.
- At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
- Experience working with sensitive populations, preferably with oncology patients.
- Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
- Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology.
- NCI/CTEP requirements of clinical trials programs, especially in terms of reporting adverse events.
- Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
- Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
- Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
- Critical thinking skills to evaluate issues and identify a potential solution.
- Clear and concise communicator; good verbal and written communication skills; both.
- Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
- Ability to cultivate relationships with multiple stakeholders at various levels of administration
- Highly organized and have the ability to prioritize projects to meet the demands of a fast-paced and dynamic work environment.
- Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
- Able to sit and work at a computer for up to 8 hours/day; stand/walk for 3-6 hours; bend/stoop for up to 3 hours; reach for up to 3 hours; repetitive use of upper extremities for up to 8 hours; able to lift and/or carry 25 pounds; able to hear alarms, clients and/or instructions. Ability to see accurately from 20 inches to 20 feet.
Preferred Qualifications
- Advanced degree preferred.
- Experience and knowledge of medical care and Phase I-III clinical trials, preferably with oncology trials.
License/Certification
- Clinical Trial Professional certification from a professional society within one year in the position.
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. Job Code and Payroll Title 009548 CLIN RSCH SUPV 1 Job Category Clinical Labs, Professional and Managerial, Research and Scientific Bargaining Unit 99 - Policy-Covered (No Bargaining Unit) Location Oakland, CA, San Francisco, CA Campus Benioff Children's Hospital, Mission Bay (SF) Additional Shift Details Monday - Friday; 40 hours/week |
University of California - San Francisco Campus and Health
Jan 13, 2025