Senior Clinical Research Coordinators independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel. The position 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 (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a 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, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. Reporting to Clinical Research Manager, the incumbent may have central responsibility for ensuring CHR approval and compliance, 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; 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. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities. Department Overview: The Division of Cardiology is one of the largest clinical, research and training divisions of the Department of Medicine (DOM) at UCSF. The Division has developed a well-established Cardiology Clinical Research Unit (CCRU) which supports 60-70 active clinical trials. The CCRU research portfolio covers phase I- IV and post approval trial types and covers a diversity of trials ranging from pharmaceutical, device, preventative, and social behavioral research. Within the Division are sub specialty sections for: Adult Congenital Heart Disease; Advanced Heart Failure, Transplant, and Pulmonary Hypertension; Cardiac Electrophysiology; Critical Care Cardiology; Cardio-Oncology and Immunology; Echocardiography and Cardiac Imaging; General Cardiology, Interventional Cardiology; and Prevention. The Divisionruns several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows through ACGME as well as non-ACGME training programs. In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine (DOM) and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, Federal, and privately supported research programs and six faculty laboratories. The Division has 80 full-time faculty, several non-faculty academics, 36 clinical fellows, several post-doctoral research fellows, and approximately 60 research support and administrative staff. The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions. While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at the Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.
% of time (Nothing less than 5%) |
Essential Function (Yes/No) |
Key Responsibilities (To be completed by Supervisor) |
25 |
Yes |
Research Operations Management:
Develop project plans,interview key sponsors, and deliver tangible project results Provide periodic statusreports to projectexecutives and coordinate documentation and archiving of project deliverables Design and performad-hoc performance analysis of the projects and the project staff Build flexible pricing and cost models to test recommended solutions against a rangeof outcomes/scenarios withinthe clinic trialsand research projects Perform business processreview, operational reviews and design and implement workflow and controls Develop project-related presentation material for study |
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Monitor key operating potential for riskto clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.) |
35 |
Yes |
Clinical TrialsManagement:
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, assigntasks, create documentation, and ensure local and federal research law compliance. Provide ongoing staff training, ensure continued compliance, coordinate amendmentupdates, maintain studyfiles, ensure auditreadiness, 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 placeto 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, andother entities, including complex audits of study performance. |
10 |
Yes |
Longitudinal CohortStudies:
Manage infrastructure before and during study execution, including database management, spaceallocation, equipment procurement, and specimen/sample storage and transportation; work with leadership to ensure proper execution of studies. Manage activities for cohorts in various areasof studies and disciplines; and for clinical trials in various disciplines. Collaboratewith other Universities, clinical entities, andindustry using collected data to understand disease progression and predictors. May contribute to or leadscientific presentations andpublications based on study data collected. May contribute to the development of new grantproposals. |
10 |
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 propercompliance with federaland local regulations to ensure audit prevention and success. Act as regulatory authority and advisorby training and educating employees and advising leadership and PI's. Manage audits. Help institute and maintain a Quality Improvement Process. |
10 |
Yes |
HR Management/Administration Assist department with recruit and train 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, and data entry. Train others in federal and local research laws and guidelines. |
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10 |
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 trialsand their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible Review budget reports on a monthlybasis. Along with thePI, create andmaintain the annualstudy budget, monitoring all items posted on ledgers, and ensuring that future budget projectionsare consistent with remaining funds. Responsiblefor ensuring thatthe use of research funding is in compliance with funding agency protocols. Assist PI in grant development, focusing on budget development. |
100% |
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(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 andpress F9. The total sum shouldadd up to 100%.) |
Required Qualifications:
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
License/Certifications:
Required Qualifications:
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
License/Certifications:
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University of California - San Francisco
48.78-78.50
Aug 19, 2026