Senior Clinical Research Lead — HIV Trials (Multi-Site)

University of California, San Francisco; San Francisco (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

University of California, San Francisco (UCSF) seeks a Senior Clinical Research Coordinator to lead the CalCURE study across six sites, overseeing regulatory compliance, protocol development and data management. You will train staff, coordinate with investigators and sponsors, and manage start-up to close-out processes to ensure high-quality clinical research operations.

The Sr CRC will oversee recruitment, enrollment and safety monitoring, ensuring adherence to GCP and FDA regulations while

Qualifications

• Three years experience as a Clinical Research Coordinator in clinical trials at UCSF or equivalent institution.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of hire date.
• In-depth knowledge of clinical trials, FDA regulations, and complex visit structures.
• Project and clinical trial management experience with regulatory responsibilities.
• BA/BS degree in a related area; or equivalent experience/training.
• Ability to develop recruitment strategies in complex environments and adapt to recruitment goals.
• Project management skills to oversee administrative operations of the trials program; budgeting awareness.
• Analytical skills with strong verbal and written communication abilities.
• Ability to operate in a changing organizational and technological environment.
• Ability to assess audit risk and develop project plans and timelines.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills and budgeting experience.
• Experience with MS Access or FileMaker Pro for data handling

Responsibilities

• Oversee all phases of CalCURE study implementations across six sites, including protocol development, recruitment, enrollment, data collection and follow-up.
• Ensure GCP compliance and regulatory requirements; prepare IRB submissions and manage regulatory files.
• Coordinate protocol development, amendments and informed consent form revisions; education materials for participants and providers.
• Maintain accurate study records, case report forms and adverse event reporting.
• Oversee participant screening, consent and follow-up; ensure safety and well-being.
• Liaise with investigators, sponsors and IRB; conduct regular team meetings and trainings.
• Coordinate training for site personnel and lead junior staff.
• Manage study start-up and close-out including regulatory submissions and subcontract setup.
• Develop recruitment strategies and materials; monitor enrollment and address barriers.
• Collaborate on data quality and participate in QA activities; support budgeting and cost analyses.

Skills

Clinical research

Regulatory compliance

Project management

Communication

Data management

Education

BA/BS degree in related area

Tools

MS Access

FileMaker Pro

Job description

University of California, San Francisco (UCSF) seeks a Senior Clinical Research Coordinator to lead the CalCURE study across six sites, overseeing regulatory compliance, protocol development and data management. You will train staff, coordinate with investigators and sponsors, and manage start-up to close-out processes to ensure high-quality clinical research operations.

The Sr CRC will oversee recruitment, enrollment and safety monitoring, ensuring adherence to GCP and FDA regulations while