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, an HCV test and treat study conducted at 6 sites in three California cities, including San Francisco.
The Sr CRC will serve as the primary study coordinator and program manager, overseeing conduct of the study at all participating sites, including study coordination, staff training, protocol and study material development, regulatory oversight, and coordination with the study team leadership, study sites, data manager, statistician and the IRB. Sr CRC will also support other SF Infectious Diseases Research Center (SF IDRC) studies as necessary
The Sr CRC role requires advanced-level knowledge and skills to be successful.
Key Responsibilities:
- Study Coordination: Oversee all phases of CalCURE study implementations including oversight of study material and protocol development, recruitment, enrollment, data collection and follow-up. Work directly with each site of six HCV Treatment Champions and site investigators to implement study
- Regulatory Compliance and Oversight: Ensure study is conducted according to Good Clinical Practice (GCP) guidelines and all relevant regulatory requirements. Prepare and submit main IRB application and renewals to central IRB, maintain shared study regulatory files, and coordinate regulatory oversight of non-San Franisco sites. Serve as the main regulatory analyst for the two San Francisco sites, responsible for all aspects of regulatory oversight, including site-specific IRB submissions, maintenance of the local regulatory file and adverse event reporting.
- Protocol Development and Study Materials: Coordinate development and implementation of protocol, protocol amendments and ICF revisions as needed, participant and treating provider education, recruitment flyers, and other study materials as necessary.
- Data Management: Contribute to and maintain accurate and complete study records, including source documentation, case report forms, and adverse event reports.
- Participant Care: Oversee screening, consent (when appropriate), and study participant follow-up activities, work with team clinicians to ensure safety and well-being of all participants throughout the trial. May perform direct study activities as above for HCV CalCURE and SF IDRC studies.
- Communication and Collaboration: Liaise with principal investigators and study personnel at all CalCURE sites, sponsors and IRB providing regular updates and addressing any issues. Plan and conduct regular all-team teleconferences, leadership team meetings, HCV Treatment Champion meetings, and investigator meetings.
- Training and Mentorship: Coordinate training, materials and study implementation for sites' HCV Treatment Champions and lead junior research staff, sharing knowledge and expertise in clinical research.
- Study Start-up and Close Out: Manage all aspects of study initiation, including regulatory submissions, subcontract set-up coordination, and close out.
- Recruitment and Enrollment: Develop and implement recruitment strategies and necessary materials to meet enrollment goals at all study sites. Coordinate with sites to track recruitment and address recruitment barriers
- Quality Assurance: Work with the data manager and treatment champions to ensure data quality and integrity and participate in quality assurance activities at all study sites.
- Finances: Develop budgets, review invoices from subcontractors and vendors, work with finance analysts to project expenditures and balances, perform cost analyses
In addition to leadership role for the CalCURE study, this position will support research efforts in the SF IDRC to include coordinating efforts for such sponsors as the Advancing Clinical Trials Globally (ACTG) a Division of AIDS (DAIDS) network, the Division of Microbiology and Infectious Disease (DMID) network and industry-sponsors such as Gilead, Glaxo Smith Kline, and Merck. Additionally, investigator-initiated studies may fall under this candidate's responsibilities. Protocol assignments will use a combination of Ontario Protocol Assessment Level (OPAL) Scoring Process and the Clinical Research Workload Tool (CRWT) to ensure balance in protocol assignments and accurate workloads.
ABOUT DIVISION OF HIV, INFECTIOUS DISEASES AND GLOBAL MEDICINE
The Division of HIV, Infectious Diseases and Global Medicine at the University of California San Francisco (UCSF) is an internationally recognized global leader in clinical care, research, and education. With its home-base located at Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG), the Division has been ranked as the top facility in the country for AIDS care since 1983. The Division's work is featured frequently in the media, and it is often visited by numerous international, national, state, and local dignitaries and delegations. The Division consists of approximately 36 faculty members, 11 fellows/postdoctoral scholars and 170 academic and staff employees. It is the largest Division of the Department of Medicine (DOM) at ZSFG, with a total expenditure budget of approximately $52 million dollars.
Required Qualifications:
- Three years experience as a Clinical Research Coordinator in clinical trials at UCSF or equivalent institution
- 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
- 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/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
- 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
- Experience using database software, such as MS Access or FileMaker Pro
Preferred Qualifications:
- Experience with HCV diagnosis and treatment research
- Implementation science research experience involving vulnerable populations and/or treatment navigation
- Bilingual English/Spanish. Able to conduct research visit in Spanish and translate for medical providers
- ALTA Qualified Bilingual Staff (QBS) Certified
- 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
License/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
%
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
30%
Yes
Research Operations Management:
- Develop and oversee study project plans, interface with key study sponsors, and deliver tangible project results
- Provide periodic status reports to principal investigator and leadership team and coordinate documentation and archiving of project deliverables
- Design and perform ad-hoc performance analysis of the projects and the project staff
- Perform business process review, operational reviews and design and implement workflow and controls
- Develop project-related presentation material for study
- Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
- Assist PI, unit manager and leadership team in grant reporting.
- Prepare budgets, track invoicing and expenditures, assist in budget projections, perform cost analyses.
60%
Yes
Clinical Trials Management:
- Coordinate and contribute to development and implementation of study protocol, ICF, source documents, HCV Treatment Champion training and support materials, patient and provider education and other study materials as needed.
- Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), train staff, create documentation, and ensure local and federal research law compliance.
- Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; ensure proper close-out of studies, and ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are deployed for compliance with regulatory requirements for the safe conduct of clinical research. Ensure all IRB documents are up to date.
- Oversee preparation of new IRB application, including master submission to the central site IRB and IRB submissions for two local San Francisco sites; coordinate paperwork for renewal of existing protocols; respond to IRB requests for revisions; and coordinate protocol changes with study sponsors and CalCURE sites.
- Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the IRB in a timely manner.
- Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
10%
Yes
HR Management/Administration:
- Train clinical research coordinators in collaboration with leadership.
- Mentor clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry.
- Train in federal and local research laws and guidelines.
- Help manage personnel needs.
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)
%
of time
Essential Function (Yes/No)
Key Responsibilities
(To be completed by Supervisor)
30%
Yes
Research Operations Management:
- Develop and oversee study project plans, interface with key study sponsors, and deliver tangible project results
- Provide periodic status reports to principal investigator and leadership team and coordinate documentation and archiving of project deliverables
- Design and perform ad-hoc performance analysis of the projects and the project staff
- Perform business process review, operational reviews and design and implement workflow and controls
- Develop project-related presentation material for study
- Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)
- Assist PI, unit manager and leadership team in grant reporting.
- Prepare budgets, track invoicing and expenditures, assist in budget projections, perform cost analyses.
60%
Yes
Clinical Trials Management:
- Coordinate and contribute to development and implementation of study protocol, ICF, source documents, HCV Treatment Champion training and support materials, patient and provider education and other study materials as needed.
- Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), train staff, create documentation, and ensure local and federal research law compliance.
- Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment; ensure proper close-out of studies, and ensure that documentation and storage of study files meets legal requirements.
- Ensure optimal systems are deployed for compliance with regulatory requirements for the safe conduct of clinical research. Ensure all IRB documents are up to date.
- Oversee preparation of new IRB application, including master submission to the central site IRB and IRB submissions for two local San Francisco sites; coordinate paperwork for renewal of existing protocols; respond to IRB requests for revisions; and coordinate protocol changes with study sponsors and CalCURE sites.
- Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the IRB in a timely manner.
- Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.
10%
Yes
HR Management/Administration:
- Train clinical research coordinators in collaboration with leadership.
- Mentor clinical research coordinators and assistants, and help them successfully perform functions including recruitment, scheduling, visit management, subject characterization, and data entry.
- Train in federal and local research laws and guidelines.
- Help manage personnel needs.
100%
(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)