Clinical Research Coordinator

Heluna Health•San Francisco, CA

8d•Onsite

About The Position

Heluna Health invites applications for one full-time position of Clinical Research Coordinator. Bridge HIV is a grant-funded research unit affiliated with the San Francisco Department of Public Health and the University of California San Francisco. Under the direction of Susan Buchbinder, MD, Bridge HIV has been conducting HIV and STI preventive vaccine studies, HIV pre-exposure prophylaxis (PrEP) studies (including oral and injectable medications), and other studies of biomedical HIV prevention strategies since the early days of the epidemic. The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods. Under the direct supervision of the Senior Clinical Research Coordinator, the Clinical Research Coordinator will help coordinate, facilitate, and manage the overall implementation of biomedical intervention studies (HIV vaccines, pre-exposure prophylaxis, and STI prevention). This position will be part of a dynamic team conducting multiple HIV and STI prevention studies.

Requirements

Demonstrates strong commitment to anti-racism and health equity
Intermediate to advanced knowledge of a variety of computer software programs, including word processing, spreadsheet, database applications (e.g. Microsoft Access), email and internet.
Extremely organized with close attention to detail in a work setting.
Strong oral/written communications skills and interpersonal/listening skills.
Willingness and ability to work as part of a collaborative team.
Experience working with ethnically, culturally, and sexually diverse populations.
Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects and confidentiality.
Knowledge of regulatory procedures including IRB submissions, renewals, and revisions.
Knowledge of HIV/STD prevention with a focus on harm reduction.
A level of education or training equivalent to a Master's degree in a related health discipline or a minimum of two (2) years of experience providing coordination, oversight, or management of a research study or similar program.

Nice To Haves

Phlebotomy certification or one year phlebotomy experience in an outpatient or inpatient setting and/or willingness to learn
Fluency in Spanish.
Previous experience in biomedical clinical research

Responsibilities

Support coordination for the clinical team according to predefined milestones, timelines and aspects of a subset of study protocols, under the guidance of the Senior Clinical Research Coordinator, to ensure successful implementation of the project plan.
Implement a subset of study protocols, including creation of protocol materials, necessary form sets, source documents, tracking systems; maintain data collection forms, logs, and databases and review informed consent documents and other protocol and site-specific documents; ensure completion of required study-specific trainings by staff.
Support overall compliance with study protocols: manage quality control systems, completion and submission of study-related documentation; assist with regular audits and other quality management activities. Recognize, track, and report protocol deviations/violations, and adverse events per protocol requirements. Ensure ethical standards of research are followed.
Manage day-to-day study activities to ensure prompt responses to study participants by study staff. Assist research associates and clinicians with telephone support calls and with study participant visits when needed.
Perform data entry of study data. Create weekly reports on study recruitment, retention, and other monitoring measures.
Provide administrative assistance to the study teams, including formulating agendas, recording of minutes, and determining action items following meetings. Work with the study investigators to resolve problems as they arise.
Coordinate communication with study sponsor, research collaborators, and other stakeholders. Participate actively on protocol team meetings and calls. Develop educational materials and educate the community regarding studies and research-related issues.
Work with the Regulatory Affairs Associate to prepare regulatory submissions and handle routine regulatory activities.
Provide oversight of laboratory issues, specimen processing, ordering of supplies, and scheduling issues.
Perform other related duties as required.