Sr. Clinical Research Coordinator - Division of HIV (Part-Time)

UCSF•San Francisco, CA

About The Position

The Senior Clinical Research Coordinator (Sr CRC) reports directly to the unit manager and, with minimal supervision, independently organizes and is accountable for the overall administration of the newly launching HCV CalCure study. The HCV test-and-treat study is conducted at six sites in three California cities, including San Francisco. The Sr CRC serves as the primary study coordinator and program manager, overseeing study conduct at all participating sites, including coordination, staff training, protocol and study-material development, regulatory oversight, and collaboration with study leadership, sites, the data manager, statistician, and IRB. The position also supports other SF Infectious Diseases Research Center (SF IDRC) studies as needed. The role includes leadership in research operations and clinical trials management, as well as staff training and mentorship. The Sr CRC supports research sponsored by ACTG/DAIDS, DMID, Gilead, GlaxoSmithKline, Merck, and investigator-initiated studies. Protocol assignments are balanced using the Ontario Protocol Assessment Level (OPAL) scoring process and the Clinical Research Workload Tool (CRWT). The position develops and oversees project plans, reports progress to principal investigators and leadership, evaluates project performance, designs workflows and controls, supports grant reporting, and manages budgets, invoices, expenditures, projections, and cost analyses. It coordinates protocol, consent-form, source-document, training, education, and other study-material development; assesses participating groups’ readiness; trains staff; manages regulatory submissions and study files; supports recruitment, enrollment, quality assurance, audits, and study close-out; and mentors clinical research coordinators and assistants. The Division of HIV, Infectious Diseases and Global Medicine at UCSF is an internationally recognized leader in clinical care, research, and education. It is based at Zuckerberg San Francisco General Hospital and Trauma Center. The division has approximately 36 faculty members, 11 fellows/postdoctoral scholars, and 170 academic and staff employees, with an expenditure budget of approximately $52 million.

Requirements

Three years of experience as a Clinical Research Coordinator in clinical trials at UCSF or an equivalent institution.
Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire.
In-depth knowledge of clinical trials, protocols, FDA regulations, and complex visit structures.
Significant project and clinical-trial management experience, or progressively responsible experience in a related position, including regulatory and compliance responsibilities.
BA/BS degree in a related area, or equivalent experience or training.
Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identify recruitment leads, implement new strategies, and adjust strategies to meet recruitment goals.
Project-management skills to oversee clinical-trial program administration and knowledge of strategies for recruiting human subjects.
Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal, and written communication skills.
Ability to analyze complex and non-routine issues and develop innovative solutions.
Ability to work effectively in a changing organizational and technological environment.
Ability to assess and respond to audit risk, develop project plans and schedules, and motivate a team to meet deadlines.
Ability to interpret and apply policies and regulations.
Financial-analysis skills, including demonstrated ability to prepare and present financial and quantitative analyses, projections, and budgets.
Experience using database software such as MS Access or FileMaker Pro.

Nice To Haves

Experience with HCV diagnosis and treatment research.
Implementation-science research experience involving vulnerable populations and/or treatment navigation.
Bilingual English/Spanish skills, including ability to conduct research visits in Spanish and translate for medical providers.
ALTA Qualified Bilingual Staff (QBS) certification.
Fluency in spreadsheet software and ability to independently develop complex spreadsheets; demonstrated audit-preparation, execution, and follow-up skills.
Experience in risk management involving 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.

Responsibilities

Oversee all phases of HCV CalCURE study implementation, including study materials and protocol development, recruitment, enrollment, data collection, and follow-up.
Work with HCV Treatment Champions and site investigators at six sites to implement the study.
Ensure compliance with Good Clinical Practice guidelines and applicable regulatory requirements.
Prepare and submit central IRB applications and renewals; maintain shared regulatory files; coordinate regulatory oversight at non-San Francisco sites; and handle regulatory oversight for the two San Francisco sites, including site-specific IRB submissions, local regulatory files, and adverse-event reporting.
Coordinate development and implementation of protocols, amendments, informed consent form revisions, participant and provider education, recruitment flyers, and other study materials.
Maintain accurate and complete study records, including source documentation, case report forms, and adverse-event reports.
Oversee screening, consent when appropriate, and participant follow-up; work with clinicians to support participant safety and well-being; and perform direct study activities as needed.
Liaise with investigators, study personnel, sponsors, and the IRB; provide updates and address issues; and plan and conduct team, leadership, Treatment Champion, and investigator meetings.
Coordinate site training and study implementation for HCV Treatment Champions and mentor junior research staff.
Manage study initiation, including regulatory submissions and subcontract setup coordination, and manage study close-out.
Develop and implement recruitment strategies and materials, track recruitment across sites, and address recruitment barriers.
Work with the data manager and Treatment Champions to ensure data quality and integrity and participate in quality-assurance activities at all sites.
Develop budgets, review subcontractor and vendor invoices, project expenditures and balances with finance analysts, and perform cost analyses.
Develop and oversee study project plans, interface with sponsors, deliver project results, provide status reports, coordinate documentation and archiving, and conduct project and staff performance analyses.
Review business processes and operations and design and implement workflows and controls; develop project presentations; monitor operational risks; and assist with grant reporting.
Assess prospective trial sites’ interest and ability to execute protocols safely and properly, including their infrastructure, staffing, and funding needs.
Maintain study files and audit readiness; coordinate protocol amendments and sponsor communications; report protocol violations and adverse events; and respond to sponsor, monitor, FDA, and other reviews or audits.
Train and mentor clinical research coordinators and assistants, support their work in recruitment, scheduling, visit management, subject characterization, and data entry, train staff on applicable research laws and guidelines, and help manage personnel needs.