Senior Clinical Research Coordinator

UCSF•San Francisco, CA

12d

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 involving diagnostic assay development and a drug-resistant tuberculosis laboratory-based study in South Africa, as well as other studies as assigned. The Senior CRC manages study communications across multiple stakeholders, ensures timely implementation of research activities, oversees operational and administrative functions, and may manage other team members. The role requires strong scientific writing and program management skills, flexibility to work across international and domestic studies, and willingness to complete tasks across levels of responsibility. Travel to study sites is required, including international travel to South Africa and potentially other locations. The position works under the direction of Project Directors and Principal Investigators. Responsibilities span research operations, clinical trials and research project management, human resources support, and financial management. This includes managing study plans, timelines, regulatory compliance, contracts, publications, databases, budgets, staff training, site visits, quality assurance, and study closeout. The role also supports Principal Investigators with troubleshooting, procurement, grant development, and budget monitoring.

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 or 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 the 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, research sites, and project staff.
Exceptional analytical skills to evaluate the importance and urgency of problems, and excellent interpersonal, verbal, and written communication skills.
Experience developing and implementing project plans and schedules and motivating teams to meet deadlines.
Intermediate to advanced database management skills, including the ability to independently develop complex spreadsheets.
Proactive, attentive to detail, well-organized, and able to multitask and meet deadlines.
Ability to travel 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 communications and facilitation support to foster 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 Committee on Human Research (CHR) approval and compliance, including preparing applications, renewals, amendments, and responses to requests.
Negotiate pre-trial agreements, budgets, and supply chains; coordinate contract execution and provide contract oversight.
Maintain study files, coordinate amendments, track enrollment, ensure audit readiness, and lead study closeout in accordance with legal requirements.
Establish systems for regulatory compliance and safe clinical research; report protocol violations and adverse events as required.
Respond to sponsor, monitor, and other entity requests and reviews, including complex study audits.
Coordinate meetings, remote communications, advisory committees, multi-site organizations, and domestic and international site visits.
Plan site visits, including travel, insurance, and security arrangements; conduct visits to evaluate site efficiency and compliance.
Create and monitor project management plans, milestones, deadlines, and project deliverables; provide status reports and coordinate documentation and archiving.
Develop and implement quality assurance and quality improvement processes and ensure compliance with GCP, the POPI Act in South Africa, and other study regulations.
Support study databases and conduct statistical analyses and database management for project monitoring or summaries.
Design and perform ad hoc performance analyses of projects and staff; develop study presentation materials and support study-specific websites.
Support Principal Investigators with budget monitoring, procurement of study supplies, and troubleshooting study issues.
Assist with recruitment, hiring, onboarding, training, and coordination of research staff; provide guidance on research activities and applicable laws and guidelines.
Monitor budgets, subcontract status, invoices, reimbursements, ledgers, expenditures, and projections; support budget revisions and appropriate use of funds.
Assist Principal Investigators with annual study budgets, grant development, and budget development.