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.

DUTIES & ESSENTIAL JOB FUNCTIONS

Identify the functions or tasks that employees in the job perform. The essential functions should state the purpose of the work and the results to be accomplished, rather than how the function is performed. Of the tasks listed, what percentage of time is devoted to each? The more time employees spend on a function, the more likely it is that the function is essential. Generally, include those functions that account for 10% or more of the work, i.e., key items that contribute significantly to the achievement of the job. The functions should add up to 100%.

%

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

60

Prepare for site monitoring visits for studies, including staff training, logistics, data management, and sample collection. Oversee data collection. Collaborate with outside vendors. Participate in the development of data collection forms for tracking study costs; tailoring forms as needed; and training local field staff to collect data utilizing site-specific forms. Communicates with researchers and provides guidance on how to resolve particular issues of concern and meet requirements of external regulatory bodies and to properly document these actions in accordance with all applicable laws, regulations, policies and procedures . Determines the appropriate level of review in triage.

25

Submit applications for IRB ethical approval, revise cover letters; update IRB applications according to changes in study design and protocol; respond to conditions and contingencies of Committee on Human Research. Analyze funding agency criteria for contracts and grants. Under general supervision, participates in pre-review and follow-up of full board committee protocols. Under the direction of the Investigators, prepare for annual DSMC meetings and quarterly DSMC calls, and monthly DSMC reports. Assist with grant writing. Participates in the development and revision of standard operating procedures and guidelines. Under general supervision, issues formal communications to funding agencies and other regulatory organization units. Generates and analyzes reports of review and approval activities.

15

Perform data management. Provide research support by programming statistical analyses including survival analysis, providing data interpretation, designing and managing databases for data collection, preparing reports for internal and external use, and ensuring the study protocol is followed. Write statistical analysis programs (descriptive and modeling). Summarize results in narrative form and with tables/graphs.

Database management: designing databases, cleaning, monitoring and conducting data quality controls on databases, assisting with data entry, and monitoring the data entry of personnel offsite.

0

0

0

0

0

0

0

0

100%

(To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

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.

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.