Limited Appointment Senior Clinical Research Coordinator

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.
 

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.

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 https://www.ucsf.edu/about/mission-and-values . In addition to , 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 https://diversity.ucsf.edu/ . Join us to find a rewarding career contributing to improving healthcare worldwide.

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.