Senior Clinical Research Coordinator Cardiology

Senior Clinical Research Coordinator 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. Responsibilities 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 evaluate recommended solutions against a range of outcomes and scenarios. Perform business process reviews and design/improve workflow and controls. Develop project‑related presentation material for study stakeholders. Monitor key operating risks to clinics, physicians, staff, and the University. Determine group interest in trial participation, assess infrastructure and staffing needs, negotiate pre‑trial agreements, and coordinate budget and ancillary setup. Provide ongoing staff training, maintain compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, track enrollment, and lead study close‑out activities. Ensure regulatory compliance for the safe conduct of clinical research and keep all CHR documents current. Oversee preparation of new CHR applications, renewal paperwork, and coordinate protocol changes with study sponsors. Respond to sponsor, monitor, FDA, and audit requests, including complex audits of study performance. Manage infrastructure for longitudinal cohort studies (database, equipment, specimen storage, and transportation). Collaborate with external universities, clinical entities, and industry to analyze disease progression and predictors. Contribute to or lead scientific presentations and publications based on study data. Support development of new grant proposals. Implement safeguards and compliance measures to protect the University from non‑compliance and potential litigation. Train and educate employees on regulatory requirements and provide guidance to leadership and principal investigators. Manage audits and help institute a quality improvement process. Assist in recruiting, training, and guiding clinical research coordinators and assistants. Oversee budgets, invoices, reimbursements, and billing accuracy to avoid improper billing. Guide subjects through financial processes and ensure accurate payment handling. Review budget reports monthly and monitor expenditures against projected funding. Co‑create and maintain annual study budgets with the principal investigator. Ensure compliance with funding agency protocols for research funding usage. Provide input and assistance in grant development, focusing on budget preparation. Qualifications BS/BA degree in a related area and sufficient experience and demonstrated skills to perform the duties, or equivalent experience/training. Ability to develop recruitment strategies in complex environments and adjust them to meet recruitment goals. In‑depth knowledge of clinical research contracts, grants, protocols, FDA regulations, and complex visit structures. Project‑management skills to oversee administrative operations of the clinical trials program. Exceptional analytical skills and excellent interpersonal, verbal, and written communication skills. Ability to analyze complex, 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 and develop project plans/schedules to meet deadlines. Ability to interpret and apply policies and regulations. Financial analysis skills with experience preparing and presenting financial and quantitative analyses, including projections and budgets. Significant project and clinical trial‑management experience, 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 and ability to develop complex spreadsheets independently. Experience in risk management regarding study subjects, federal and non‑federal sponsors, and regulatory 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. 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: 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. #J-18808-Ljbffr University of California, San Francisco