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Job Summary: Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection. 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.
% of time |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
30 |
Yes |
Distributes work. Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Reports performance evaluation to management. Supervises the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations. *Train, supervise, CRCs in coordinating clinical studies emphasizing the priority of patient safety and timely data reporting for CTEP, industry sponsored, and Investigator-sponsored studies while maintaining scientific integrity of the study. -Train, supervise, CRCs for reviewing medical history, performing study procedures, collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events, using medical charts and electronic records to extract medical information, and utilizing various data collection instruments including databases of sponsored studies, OnCore, iMEDris, and Apex EMR. |
15 |
Yes |
Follows internal policies and processes. Supervises assigned staff to ensure compliance. Trains employees on research regulatory processes, database entry, and working with participant families. Implements and maintains defined research study processes. * Acts as resource to CRC, to ensure accuracy in eligibility verification for each patient placed on a clinical trial to ensure human subject protection regulations comply and quality recruitment. *Acts as resource to CRC in study startup. Helps troubleshoot logistics as needed by CRC and helps conduct and attends all relevant SIV meetings with sponsors and external sites. May be required to complete study start-up independently and then train CRC. |
10 |
Yes |
Serves as a liaison between staff and program leaders. Reports work effort to the department. Cultivates communication and teamwork between cross-functional teams working on research. *Work with Clinical Research Manager and CRC team to implement needs assessments and recommendations for enhancements on patient coordination, data collection, data management, protocol adherence and study collaboration to improve efficiency, maximize limited resources, and deliver optimal clinical trial experience for patients and high-quality data. * Field questions, explore issues, and support CRCs in problem solving on the day-to-day level; recognizes trends and discusses with Clinical Research Manager to ensure that trends are addressed on a broad scale |
25 |
Yes |
Initiates a clinical trial study. Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed. Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment. Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety. *Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, and UCSF regulations. *Initiate and follow-up on iRIS submissions for single-patient exceptions, adverse event reporting, and protocol violations. *Maintain regulatory documents; monitor timelines for data submission; document adverse events and submit to appropriate departments. *Use sound judgment to maintain patient confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments. *Participate in and cooperate with any internal and external audits or reviews of study protocols; prepare necessary documentation. *Facilitate start-up and study coordination at external sites for multi-site investigator initiated studies; |
5 |
Yes |
Monitors and audits visits. Monitors preparation in order to oversee and assist study coordinators in preparing for audits. Ensures data is sufficient and updated, including all regulatory documentation. Uses computer applications to generate reports and quality assurance of required data entry. Attends all meetings with auditors. Assists staff assigned with monitoring site compliance. *Trains, supervises, and guide CRCs to prepare for monitoring and audit visits, including ensuring all study documents are complete, organized, and current, all data is submitted and queries answered, and all action items from prior visits are completed *Trains, supervises, and guide CRCs to ensure optimal communication with industry, institutional, external site, and cooperative group monitors and auditors *Reviews and analyzes monitoring and audit reports for industry-sponsored, investigator initiated, and cooperative group studies to ensure action items are completed *Identifies and addresses key areas for improvement related to training and performance management *In conjunction with the Clinical Research Manager, identifies areas where process improvements are needed |
5 |
Yes |
Tracks patient charges and alerts the department on billable triggers to collect money. Understands budget preparation for clinical trials; interprets and trains the study coordinators on how to proceed in proper data research billing. Coordinates with billing to resolve disputed charges. *Trains, supervises, and guide CRCs to consult and interpret coverage analyses, communicate billing practices to patients, and properly and in a timely manner route billing of study procedures via electronic billing systems. *May offload more complicated billing issues from CRCs. *May collaborate with partners in ancillary departments, including clinic team, billing offices, and information technology team to troubleshoot individual instances of improper billing; communicates with Clinical Research Manager to facilitate recognition of trends and improve processes *May be responsible for working with Clinical Research Manager and Protocol Project Manager in managing the funds for the study, including assisting with tracking and reporting invoiceables to the post-award team to ensure timely patient reimbursement *Provides excellent judgment and initiative to ensure procedures are properly billed to optimize patient care and use of limited resources, may assist Clinical Research Manager in creating systems to ensure these operations are properly implemented |
5 |
Yes |
Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and orientation of new employees. Evaluates assigned staff performance and reports to management. Provides guidance and excellent judgement. Seen as a role model by assigned staff. |
5 |
Yes |
Act as backup for CRCs to cover operation as needed |
100% |
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Minimum Required:
- Bachelor's degree in related area.
- Clinical Trial Professional certification from a professional society within one year in position.
- Minimum of 1 year Lead/Supervisory/Manager experience.
- Minimum of 3 years of related experience.
- At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
- 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 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.
- Clinical Trial Professional certification from a professional society within one year in position.
- Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
- Experience working with sensitive populations, preferably with oncology patients.
- 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.
- 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.
- 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:
- Advanced degree preferred.
- At least 1 years experience with industry clinical trials as a CRC.
- 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 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 here.
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.
Salary Information
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.
To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Minimum Required:
- Bachelor's degree in related area.
- Clinical Trial Professional certification from a professional society within one year in position.
- Minimum of 1 year Lead/Supervisory/Manager experience.
- Minimum of 3 years of related experience.
- At least one year of experience in project/program coordination, preferably in clinical trials, either at UCSF or at another academic or research institution.
- 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 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.
- Clinical Trial Professional certification from a professional society within one year in position.
- Knowledgeable in the IRB requirements as well as FDA regulations for human subject safety.
- Experience working with sensitive populations, preferably with oncology patients.
- 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.
- 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.
- 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:
- Advanced degree preferred.
- At least 1 years experience with industry clinical trials as a CRC.
- 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 position.
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University of California - San Francisco
115k - 130,000
May 29, 2026