|
This is a limited appointment ending June 30, 2027. The Senior Clinical Research Coordinator independently coordinates and is accountable for the overall administration of several clinical studies, requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. This role may serve several divisions within the department including but not limited to: hematology, medical genetics and allergy/immunology/BMT. They may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies. The Senior CRC is responsible for, and critically important to, the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials, local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff administration, IRB, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. Reporting to the Clinical Research Supervisor, the Senior CRC's duties may include: central responsibility for ensuring IRB approval and compliance, budget and contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; 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; exercise strong administration and management leadership of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial, oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes; coordinate staff work schedules and assist the Clinical Research Supervisor and/or PI with oversight and training of other research staff; manage Investigator's protocols in the IRB online system, as well as renewals and modifications of protocol applications and the implementation of new studies; participate in the review and writing of protocols to ensure institutional review board approval within University compliance; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; participate in any internal and external audits or reviews of study protocols.
% of time |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
30 |
YES |
Clinical Trials Management
- Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), negotiate pre-trial agreement and budget, work with Research Services Analyst and Industry Contracts to execute agreement, set up ancillary departments, train staff, assign tasks, create documentation, and ensure local and federal research law compliance.
- Schedule subjects for study visits; meet with them to administer questionnaires, collect medical history and perform study procedures.
- Maintain rapport and relationships with subjects to ensure effective communication and retention; respond to their diverse needs, schedule follow-up appointments, and become their intermediary; discuss study outcomes with providers to ensure continuity of care.
- Obtain informed consent; review information with subjects; assess and advocate for patient safety throughout each protocol procedure.
- Oversee subject reimbursement; work to resolve discrepancies and issues.
- Work with staff to ensure procedures are completed, specimens properly stored, and required data collected at visits; and ensure correct shipping and labeling measures.
- Coordinate, communicate and network with other studies and technicians to ensure scheduling efficiency; communicate with any affiliated groups.
- Conduct reviews of medical charts and electronic records to extract medical information and other data for use in studies.
- Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. Ensure all CHR documents are up to date.
- Oversee preparation of new CHR applications; arrange paperwork for renewal of existing protocols; respond to CHR requests for revisions; and coordinate protocol changes with study sponsors.
- Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner.
- Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
|
10 |
YES |
Data management and reporting of results
- Collect data during subject visits; enter data from visits, procedures, lab tests, and other subject-related participation into databases in a timely manner.
- Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed.
- Create and maintain comprehensive data sets as requested by the CRC Supervisor and/or PI.
- Maintain data collection forms for effective data collection, entry, and analysis.
- Perform queries and analysis in databases.
- Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
|
10 |
YES |
Research Operations Management:
Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables Design and perform ad-hoc performance analysis of the projects and the project staff Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects Perform business process review, operational reviews and design and implement workflow and controls Develop project-related presentation material for study Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.) |
10 |
YES |
HR Management/Administration:
- Assist department with recruiting and training clinical research coordinators in collaboration with leadership.
- Provide guidance to clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, changes in procedures, study protocols, data collection/entry, database procedures, medical chart review and storage, and other procedures.
- Train others in federal and local research laws and guidelines.
- Help manage personnel needs as needed.
- Attend and actively participate in regular team meetings
|
25 |
YES |
Financial Management
- Oversee budgets, invoices, and reimbursements.
- Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients.
- Guide subjects through financial process (private vs. federal trials and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible
- Review budget reports on a monthly basis.
- Along with the PI, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds.
- Responsible for ensuring that the use of research funding is in compliance with funding agency protocols.
- Assist PI in grant development, focusing on budget development.
|
10 |
YES |
Protocol Submissions and Adherence
- Enter all existing and new study protocols into the Committee on Human Research (CHR) online system; seek assistance on maintaining all protocols in the system by communicating with CHR Analysts.
- Design and enhance case report forms and data collection forms as needed; provide manuscript feedback; continue to develop and maintain systems for assuring protocol adherence and data quality.
- Participate in the review and writing of protocols and related procedures to ensure institutional review board approval within University compliance.
- Renew, modify, and submit CHR applications and protocols; ensure that protocol applications are submitted in a timely manner; serve as a liaison between CHR and study Investigators.
- Provide quality assurance checks to note if protocols or UCSF CHR applications need to be modified; evaluate protocols on an ongoing basis and implement improvements as needed.
|
5 |
Yes |
Risk Management
- Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws; implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success.
- Act as regulatory authority and advisor by training and educating employees and advising leadership and PI's.
- Manage audits.
- Help institute and maintain a Quality Improvement Process.
|
|
|
|
100% |
|
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.) |
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.
- Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions and companies; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- 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.
Required Licenses and/or Certifications:
- 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
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.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
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 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.
- Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions and companies; and the ability to multi-task in a fast-paced environment while working with a diverse subject population.
- Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines.
- 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.
Required Licenses and/or Certifications:
- 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
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.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.
|
University of California - San Francisco
46.02-74.02
Jul 09, 2026