Senior Clinical Research Coordinator

University of California, San Francisco•San Francisco, CA

11d

About The Position

The Senior Clinical Research Coordinator (CRC) is an experienced professional who independently coordinates and is accountable for the overall administration of one or more clinical and implementation studies, requiring advanced-level knowledge and skills. The role supports a domestic industry collaboration focused on diagnostic assay development and a drug-resistant tuberculosis laboratory-based study in South Africa, as well as other assigned studies. The Senior CRC manages communications among multiple stakeholders, ensures timely implementation of research activities, oversees operational and administrative functions, and may manage other team members. Travel to study sites, including international locations such as South Africa, is required. Under the direction of Project Directors and Principal Investigators, the Senior CRC develops plans to meet research commitments; supports collaboration among study stakeholders; develops scientific publications and reports; manages team members, deliverables, timelines, and dissemination; and oversees human research approvals and compliance. The position also supports contract negotiations and oversight, study databases, statistical analyses, project monitoring, budget monitoring, procurement, and troubleshooting for pragmatic trials and implementation research. Responsibilities include research operations management; clinical trials and research project management; human resources support; and financial management. The Senior CRC oversees study agreements, budgets, supply chains, staff training and assignments, regulatory compliance, study files, enrollment, audit readiness, close-out, CHR applications and amendments, protocol violation and adverse-event reporting, sponsor and monitor reviews, meetings, site visits, QA/QC processes, and project plans. The role also assists with staff recruitment, onboarding and training, budget and subcontract monitoring, billing and reimbursements, annual study budgets, and grant development. Travel may be up to 20% to domestic sites and 4–6 weeks per year to international sites. The position requires strong scientific writing and program management skills, adaptability across international and domestic studies, and willingness to complete tasks regardless of level of responsibility.

Requirements

BS/BA degree in a related area and/or equivalent experience or training.
Sufficient experience and demonstrated skills to perform the assigned duties and responsibilities, or equivalent experience/training.
In-depth knowledge and experience with clinical research and/or implementation research contracts and grants, clinical trials, protocols, and complex visit structures.
Project management skills to oversee administrative operations of clinical trials and implementation research activities.
Strong communication and facilitation skills, including experience supporting multi-stakeholder collaborations.
Experience working in an international research setting and communicating and building relationships with international partners, including Ministries of Health, commercial entities, international university faculty or research sites, and project staff.
Exceptional analytical skills to evaluate the importance and urgency of problems.
Excellent interpersonal, verbal, and written communication skills.
Experience developing and implementing project plans or schedules and motivating teams to meet deadlines.
Intermediate to advanced database management skills, including the ability to develop complex spreadsheets independently.
Highly proactive, attentive to detail, well-organized, and able to multitask and meet deadlines.
Travel availability of up to 20% to domestic sites and 4–6 weeks per year to international sites.
Certification by the Society of Clinical Research Associates or Association of Clinical Research Professionals, or ability to obtain certification within one year of hire.

Nice To Haves

Master’s degree in public health, public policy, or a related field.
Knowledge and experience in TB, HIV, and/or COVID-19 research.
Proficiency in statistical software.
Experience with grant application procedures, personnel documentation, contract generation, and subcontracting.

Responsibilities

Develop plans to meet research commitments and ensure timely implementation of research activities.
Provide high-level communication and facilitation support to promote collaboration among study stakeholders.
Write, develop, and manage scientific publications, reports, articles, and other written materials from concept through final production.
Manage team members, deliverables, timelines, and dissemination of reports and publications.
Ensure human research approval and compliance, including keeping CHR documentation current and coordinating applications, renewals, revisions, and protocol changes.
Manage study-partner contract negotiations and provide contract oversight.
Support study databases, conduct statistical analyses, and perform database management for project monitoring and summaries.
Support Principal Investigators with budget monitoring and procurement of study supplies.
Troubleshoot issues arising in pragmatic trials and implementation research studies.
Prepare status reports, coordinate documentation and archiving, assist with publication-ready reports, perform ad-hoc project and staff performance analyses, and develop project presentations.
Monitor operational risks and support development of study-specific websites.
Negotiate pre-trial agreements, budgets, and supply chains; coordinate agreement execution and set up ancillary departments.
Train staff, assign tasks, create documentation, and ensure compliance with in-country research laws.
Maintain study files, ensure audit readiness, track enrollment, lead study close-out, and ensure legally compliant documentation and storage.
Ensure systems support regulatory compliance and the safe conduct of clinical research.
Report protocol violations to sponsors and adverse events to the CHR in a timely manner.
Respond to sponsor, monitor, and other entity requests and reviews, including complex study audits.
Coordinate study meetings, remote communications, site visits, travel, insurance, and security planning.
Create and monitor project management plans and milestones, and work with investigators and staff to meet deadlines.
Coordinate advisory committees and communications with multi-site organizations.
Develop and implement QA/QC processes and ensure compliance with GCP, the POPI Act in South Africa, and other study regulations; conduct site visits and implement QA and QI processes as needed.
Assist leadership with research staff recruitment, training, coordination, hiring, interviewing, and onboarding.
Guide research staff in recruitment, scheduling, visit management, subject characterization, and data entry; train others on international, federal, and local research laws and guidelines.
Monitor budgets, subcontracts, invoices, reimbursements, expenditures, billing, and budget projections; work with post-award staff to support appropriate use of funds.
Create and maintain annual study budgets with the Principal Investigator and assist with grant development, including budget development.