Senior Clinical Research Coordinator, Liver Biorepository

About the role

The 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. This position is critically important to the operational management of the IELB and the liver disease research it supports.

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 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
• Maintain IRB (CHR) applications and approvals, coordinate studies, and actively publicize the biorepository’s available samples to investigators at UCSF and externally to maximize their scientific use
• Prepare and maintain IRB (CHR) applications and approvals, coordinate studies, and actively publicize the biorepository’s available samples to investigators at UCSF and externally to maximize their scientific use
• Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research
• Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance
• 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
• 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
• Institute and maintain a Quality Improvement Process
• 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
• Aid in the recruitment and training of clinical research coordinators in collaboration with leadership
• Train others in federal and local research laws and guidelines
• Help manage personnel needs as needed
• 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
• Create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds
• Ensure that the use of research funding is in compliance with funding agency protocols
• Assist PI in grant development, focusing on budget development

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
• 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
• 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
• 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
• 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 have 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 with the communities we serve.