Research Study Coordinator – Public Health Foundation Enterprises, In – San Francisco, CA

Job title: Research Study Coordinator Company: Public Health Foundation Enterprises, In Job description: 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 Research Coordinator 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. This is a temporary, grant-funded, full-time, benefited position. Employment is provided by Heluna Health. Pay rate: Starting at $70,000 annually commensurate with experience If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date, or have a valid religious or medical reason qualifying you for an exemption (that may or may not require accommodation). ESSENTIAL FUNCTIONS • 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. NON-ESSENTIAL FUNCTIONS • Participating in weekly Clinician and Epidemiology team meetings and Journal Club • Perform other related duties as assigned. JOB QUALIFICATIONS Education/Experience • 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 Certificates/Licenses/Clearances • 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; PHYSICAL DEMANDS Stand Frequently Walk Frequently Sit Frequently 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 See Constantly 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) WORK ENVIRONMENT General Office Setting, Indoors Temperature Controlled Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and the disabled to apply All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance EEOC STATEMENT 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. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) See job description Expected salary: $70000 per year Location: San Francisco, CA Job date: Sun, 28 Aug 2022 22:55:40 GMT Apply for the job now! Apply tot his job Apply To this Job