Project & Policy Analyst III

Job Description

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), exhiting an in-depth knowledge of specific programs.

Reporting to a Principal Investigator (PI) or Director, 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.

The Human Research Program Manager independently manages the day-to-day human research operations of the Bodansky Laboratory and the CHAMP program. Using broad knowledge of clinical research operations, the incumbent coordinates clinical research coordinators (CRCs), prospective participant identification and enrollment workflows, biospecimen collection and transfer, the CHAMP biorepository, regulatory documentation, data and specimen quality, and communication among clinical and laboratory teams. The incumbent translates scientific priorities into reliable operational plans, develops and improves standard operating procedures, tracks deliverables and risks, and resolves diverse operational problems with substantial independence. The role requires excellent organization, judgment, discretion, and interpersonal skill in a sensitive pediatric clinical environment.

Department Overview

The Bodansky Laboratory is part of the UCSF Department of Pediatrics, Division of Pediatric Critical Care Medicine. The laboratory studies pediatric critical illness, immune dysregulation, autoimmunity, and enigmatic pediatric disease by connecting bedside observation, prospective human biospecimen collection, and advanced immune profiling. The lab's human research portfolio includes the CHAMP (Child Health Advanced Molecular Phenotyping) program, a clinical research and biorepository infrastructure designed to learn from children with rare, severe, or incompletely understood inflammatory or immune-mediated illnesses.

The team works closely with patients and families, clinical research coordinators, physicians, nurses, laboratory staff, institutional research offices, and collaborators across UCSF and other institutions. We value scientific rigor, reliable execution, thoughtful stewardship of human biospecimens and data, clear communication, humility, and a deep commitment to improving outcomes for critically ill children.

Qualifications

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. - 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.