Study Coordinator

About the Role

Involves staffing, administering, or managing research oversight and compliance committee activities related to research activities such as human subjects, animal use and care, conflict of interest, and export control. Reviews research protocols for use in specific fields, assists in writing and reviewing protocols, and ensures compliance with federal, state, and University mandated laws, regulations, and policies.

The Research Compliance Analyst 2 (internal title: Study Administrator) assists the study team and investigators with research activities in locations worldwide. Responsibilities include preparing for study implementation, refining study protocols, obtaining regulatory and ethical approvals, and performing remote and in-person site visits. Additional duties involve assisting with grant and manuscript writing, data management and analysis (e.g., designing data collection forms, data cleaning, and participating in data analysis), monitoring adherence to study protocols across sites, and serving as a liaison to study personnel at enrollment sites. This role also includes preparing monitoring reports for the NIH and Data Safety Monitoring Committees and managing study funds across all sites.

Using research compliance concepts, applies organization policies and procedures to review and/or pre-review moderately complex, minimal-risk research protocols. Works independently on routine or standard assignments with minimal supervision or oversight. Occasionally pre-reviews or highlights potential issues for department head or full committee consideration in their review of research protocols that qualify for full committee review.

About the Department

The Francis I. Proctor Foundation for Research in Ophthalmology at UCSF is committed to engaging in research activities and providing state-of-the-art patient care that address infectious and inflammatory diseases causing blindness. The mission is the prevention of blindness worldwide through research and teaching focused on infectious and inflammatory eye disease.

Responsibilities

• Assist in staffing, administering, or managing research oversight and compliance committee activities.
• Review research protocols for compliance with federal, state, and University regulations.
• Refine study protocols and obtain regulatory and ethical approvals.
• Perform remote and in-person site visits for study implementation.
• Assist with grant and manuscript writing.
• Design data collection forms, clean data, and participate in data analysis.
• Monitor adherence to study protocols across study sites.
• Serve as a liaison to study personnel at enrollment sites.
• Prepare monitoring reports for the NIH and Data Safety Monitoring Committees.
• Manage study funds across all sites.
• Pre-review or highlight potential issues for department head or full committee review.

Qualifications

• Bachelor’s degree in a related area and/or equivalent experience/training.
• 2 years of experience in administrative analysis, operations research, or an equivalent combination of education and experience.
• 1-2 years of experience with study coordination.
• Experience with statistical software packages (R or STATA).
• Independence, planning, and decision-making abilities to complete assigned duties.
• Strong writing and communication skills.
• Ability to work in a team-oriented setting, prioritize work, and follow through on routine assignments with minimal direction.
• Strong organizational skills, ability to multitask, and work with frequent interruptions.
• Problem-solving skills; ability to listen, interpret, and confirm understanding of others' communications; and objectivity.
• Knowledge of database management.
• Understanding of HIPAA and IRB approval process.
• R programming ability.
• Experience in writing, editing, and reviewing scientific manuscripts.
• Experience conducting literature reviews and writing scientific papers.

Preferred Qualifications

• Graduate degree in public health, nursing, epidemiology, or a related field.
• Experience managing complex medical research studies, including multi-center clinical trials.
• Experience working with international sites or cross-cultural communication.
• Relevant compliance certification (if applicable).