Study Coordinator

JOB SUMMARY

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 compliance with federal, state, and University mandated laws, regulations and policies.

The role of the Research Compliance Analyst 2 (internal title: Study Administrator) is to assist the study team and investigators with research activities in locations worldwide. The incumbent will be expected to assist the team in preparing for study implementation, including refining study protocols, obtaining regulatory and ethical approvals, and performing remote and in-person site visits. They will also assist with grant and manuscript writing, and data management/analysis such as designing data collection forms, data cleaning, and participating in data analysis. This individual will monitor adherence to the study protocol across study sites, and serve as a liaison to study personnel at enrollment sites. This individual will also help prepare monitoring reports for the NIH and Data Safety Monitoring Committees. This position will also involve management of 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 in most cases without a great deal of supervision or oversight for routine or standard assignments. Occasionally pre-reviews or highlights potential issues of concern for department head or full committee to consider in their review of research protocols that qualify for full committee review.

DEPARTMENT DESCRIPTION

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 disease that cause blindness. The mission is the prevention of blindness worldwide through research and teaching focused on infectious and inflammatory eye disease.

REQUIRED QUALIFICATIONS:

• Bachelor's degree in related area and / or equivalent experience / training.
• 2 years experience in administrative analysis or operations research or an equivalent combination of education and experience
• 1-2 years’ experience with study coordination
• Experience with statistical software packages (R or STATA)
• Independence, planning and decision making abilities to complete assigned duties
• Strong writing/communication skills
• Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction
• Strong organizational skills, the ability to multi-task, and work with frequent interruptions.
• Ability to problem solve issues; listen, interpret and confirm understanding of others' communications; and, to be objective
• 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 related field
• Experience managing complex medical research studies including multi-center clinical trials
• Experience working international sites or cross-cultural communication
• Relevant compliance certification (if applicable) preferred.