Job Description:
Senior Clinical Research Coordinator independently coordinates and is accountable for the overall operation of the Ibrahim El-Hefni Liver Biorepository (IELB) and its associated clinical research studies at UCSF. Requiring advanced-level knowledge and skills, the incumbent serves as the operational and regulatory lead for the biorepository—overseeing biospecimen collection, processing, annotation, and distribution—and provides leadership to other clinical research coordinators and support personnel within the program. This position is critically important to the operational management of the IELB and the liver disease research it supports. It has direct responsibility for managing a biospecimen repository—including blood, serum, plasma, and liver tissue linked to richly annotated clinical data—along with the longitudinal cohort studies and investigator-initiated protocols that feed it. The incumbent prepares and maintains IRB (CHR) applications and approvals, coordinates studies, and actively publicizes the biorepository's available samples to investigators at UCSF and externally to maximize their scientific use. The role requires expert integration of regulatory, operational, and data‐management activities, applying a sophisticated medical and immunology knowledge base and substantial leadership skills, and working effectively with clinicians, investigators, clinical staff, the Committee on Human Research, and contracts and grants staff at UCSF, as well as with external collaborators, sponsors, and NIH.
Responsibilities:
Research Operations Management Develop project plans, interview key sponsors, and deliver tangible project results. 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. Clinical Trials Management Serve as the primary regulatory coordinator for the biorepository and associated studies: prepare, submit, and maintain IRB (CHR) applications, continuing reviews, modifications, and safety reports; ensure all protocols, consent forms, and biospecimen collection activities remain in continuous compliance with IRB and institutional requirements. Determine interest of groups in trial participation, assess ability to execute protocol safely and properly, negotiate pre‐trial agreements and budget, and coordinate with Research Services Analyst and Industry Contracts to execute agreements. Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment. Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research. 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. Longitudinal Cohort Studies Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation. Manage activities for cohorts in various areas of studies and disciplines; and for clinical trials in various disciplines. Collaborate with other Universities, clinical entities, and industry using collected data to understand disease progression and predictors. May contribute to or lead scientific presentations and publications based on study data collected. May contribute to the development of new grant proposals. 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 PIs. Manage audits. Help institute and maintain a Quality Improvement Process. HR Management / Administration Provide guidance and day‐to‐day leadership to other clinical research coordinators and support staff within the IELB, including assigning and reviewing work, training, mentoring, and coordinating workload to meet collection, regulatory, and data‐quality goals. Assist department with recruiting and training clinical research coordinators in collaboration with leadership. Help manage personnel needs as needed. 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 the financial process to ensure accurate payments. Review budget reports on a monthly basis. Create and maintain the annual study budget with the PI. Ensure compliance with funding agency protocols. Assist PI in grant development, focusing on budget development.
Qualifications:
Bachelor's degree in a related area and 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. In‐depth knowledge of clinical research contracts and grants, clinical trials, protocols. Project management skills to oversee the administrative operations of the clinical trials program. Exceptional analytical skills to evaluate the importance and urgency of problems; excellent 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 interpret and apply policies and regulations. Financial analysis skills and experience in preparing and presenting financial and quantitative analyses. 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 hire.
Preferred Qualifications:
Fluency in spreadsheet software; ability to develop complex spreadsheets independently. 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. 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. 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. 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. Join us to find a rewarding career contributing to improving healthcare worldwide.
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
