Research Study Coordinator
- Experience Level
Heluna Health invites applications for a full-time Research Study Coordinator to work in the San Francisco Disease Prevention and Control Branch, Population Health Division as part of the SF City Clinic (SFCC) Research Team. The SFCC research program is focused on investigating treatments, diagnostic tests, and prevention tools for sexually transmitted infections (STIs) and HIV.
The Research Study Coordinator will be responsible for the overall operational management of clinical research activities. They will directly supervise work assignments and schedules of research staff members to meet clinical research goals and timelines; will recruit, orient, and train new employees and perform ongoing assessments of workloads and productivity; will collaborate with study investigators and research staff at SFCC and the San Francisco Department of Public Health.
The coordinator will oversee study recruitment, enrollment, follow-up, retention, and data management. They will assist with developing and maintaining study protocols and documentation and communicating with the primary investigator, clinic personnel, study sponsors, laboratories, and regulatory agencies. In addition, the coordinator will work alongside the research associates to screen and enroll study participants; conduct study visits; maintain biologic logs; coordinate patient related activities including arranging necessary appointments and procedures; and coordinate specimen shipment per IATA guidelines. The CRC will also be responsible for the preparation of all documents and reports required by the Institutional Review Board (IRB) and CRO’s, in order to communicate the study progress and report adverse events or protocol violations as needed.
Current ongoing studies at City Clinic include 1) DoxyPEP: A randomized controlled study of doxycycline post-exposure prophylaxis to prevent sexually transmitted infections and 2) A randomized controlled study of zoliflodacin for the treatment of uncomplicated gonococcal infection.
This is a temporary, grant-funded, full time, benefited position. Employment is provided by Heluna Health.
Salary is starting at $67,995.20 annually and commensurate with experience
- Oversee study recruitment, enrollment, and follow-up processes and manage participant visit schedule.
- Implement study specific procedures with strict adherence to the study protocol.
- Assure careful compliance with IRB standards and policies in all study activities.
- Manage daily study operations, including planning and forecasting progress of study and staffing needs; assigning staff to study visits; providing triage and problem-solving for schedule changes and complicated participant visits; coordinating clinicians, counselors, and research associate for study visits and administrative work; working with San Francisco City Clinic staff to integrate study visits into regular clinic operations.
- Consent and enroll new study participants and conduct study follow-up visits
- Oversee the hiring process for study counselors and research associates, including writing job descriptions, reviewing CVs and scheduling and conducting interviews.
- Supervise and evaluate study counselors/research associates (RA) and other study staff.
- Write and maintain study protocols and operational manuals
- Manage protocol submission and documentation for approval to the UCSF Committee on Human Research (CHF) or central IRBs prior to study initiation and for renewals
- Correspond with study sponsor and research collaborators.
- Oversee study data collection and management. Oversee data entry of study participant data at the site and manage and respond to queries from the data management team.
- Performing weekly quality control of all study documents
- Create regular reports to monitor study recruitment, retention, and safety monitoring measures.
- Provide oversight of laboratory issues, specimen processing, ordering of supplies and study drug inventory. Assist with specimen collection, preparation, handling, storage and shipping as needed.
- Prepare progress reports for protocol safety review team (PSRT) and funding agencies.
- Report adverse events or protocol violations as needed.
- Write and implement all protocol related memos to file, letter of amendments and protocol modifications.
- Coordinating site visits from sponsor and regulatory agency staff
- Create agreements and continue communication with outside agencies such as laboratories and pharmacies.
- Submitting project invoices and updating study budgets
- Participate in planning, training, evaluation meetings, QA meetings, and conference calls, as necessary or requested, including travel as needed for training
- Maintain organized study files and uphold strict confidentiality of study related records at all times.
- Working with City Clinic Principal Investigators to review, process and finalize responses to site questionnaires for proposed studies and Clinical Trial Agreements
- Other duties as assigned.
- Participating in weekly Clinician and Epidemiology team meetings and Journal Club
- Perform other related duties as assigned.
- BA/BS in related field, or a combination of relevant experience and education
- Minimum 3-years experience coordinating studies in public health or clinical
- Extensive knowledge of STI/HIV infection, transmission and prevention
- Experience applying regulations and guidelines such as Good Clinical Practice Guidelines, Health Insurance Portability and Accountability Act (HIPAA), the Protection of Human Research Subjects, IRB regulations for recruitment and consent of research subjects
- Experience writing detailed reports or IRB submissions
- Fluency in the usage of Committee of Human Research (CHR) online iMedRIS system for submission, renewal, and modification of protocols
- Experience supervising, managing, and training research staff
- Experience with diverse communities, particularly communities of color, LGBTQ, and substance using communities. Understanding of patient population to create rapport, while also giving insight to what is realistic and appropriate for patient participation
- Experience managing and analyzing data in Microsoft Access, Excel, Stata, or related programs
- Human Subjects and Good Clinical Practice Training
- IATA Training
Other Skills, Knowledge, and Abilities
- Ability to operate a computer and proficiency in the use of Microsoft Office Suite software including Microsoft Word and EXCEL
- Excellent oral and written communication skills
- Strong organizational and time management skills; high level of attention to detail
- Good problem-solving skills
- Ability to prioritize and handle multiple tasks and to work independently in a high-pressure environment
- Sensitivity to ethnically, culturally, economically, and racially diverse populations
- Comfortable discussing sexual behavior and HIV transmission risks
- Providing and maintaining a customer service atmosphere which incorporates the standards and protocols of the San Francisco City Clinic;
- Ability to develop and maintain organized study record systems;
- Ability to work in a high-volume, fast paced environment;
- Ability to follow strict research protocol and SOP (standard operating procedures) guidelines;
- Ability to adapt to new procedures;
Handling / Fingering Frequently
Reach Outward Frequently
Reach Above Shoulder Occasionally
Climb, Crawl, Kneel, Bend Occasionally
Lift / Carry Occasionally - Up to 25 lbs
Push/Pull Occasionally - Up to 25 lbs
Taste/ Smell Not Applicable
Not Applicable Not required for essential functions
Occasionally (0 - 2 hrs/day)
Frequently (2 - 5 hrs/day)
Constantly (5+ hrs/day)
General Office Setting, Indoors Temperature Controlled
Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply.
All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance
Please apply at the following URL: https://recruiting2.ultipro.com/PUB1001PUBH/JobBoard/6705aa07-0bcb-4660-ad1b-2fda952becc7/OpportunityDetail?opportunityId=f866fd10-7946-4e3f-9a30-a89464ad6e80
It is the policy of Heluna Health to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.