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Heluna Health · 1 month ago

Research Study Coordinator

San Francisco, California, United States

Full-time

Onsite

Mid, Senior Level

$80K/yr - $88K/yr

3+ years exp

Heluna Health is seeking a full-time Research Study Coordinator for their Center on Substance Use & Health, a research unit within the San Francisco Department of Public Health. The role involves overseeing and coordinating studies related to substance use, ensuring adherence to protocols, and managing study databases and staff.

Health CareNon ProfitSponsorship

Comp. & Benefits

Responsibilities

Oversee and coordinate observational and intervention studies addressing substance use, including coordinating study start-up, ensuring that studies are enrolling according to goals; support staff to meet these goals using data-driven problem-solving

Oversee the development and implementation of standard operating procedures (SOPs) and study specific protocols (SSPs) and ensure adherence of study staff to protocols and the principles of Good Clinical Practice (GCP)

Oversee the development of study intervention materials such as qualitative interview guides, counseling manuals, etc

Facilitate weekly meetings and supervise research associates and other staff working on studies; provide guidance as a supervisor, conduct regularly scheduled supervisory meetings with direct reports

Ensure that study staff are up-to-date with all training requirements, licenses and certifications

Oversee, plan for, manage, and problem-solve the data needs of the Unit including creating and modifying survey instruments, interview guides, and case report forms

Oversee and provide management of study databases, including activities such as chart abstractions from medical records

Create, oversee, and manage the quality control systems for research records, study data, and regulatory obligations

Recruit for and manage focus group sessions and qualitative interviews according to study protocols

Under the guidance of the CRPM, manage regulatory affairs of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Data Safety Monitoring Board, the Food and Drug Administration (FDA), and other funding or regulatory agency reports

Generate as-needed reports for study team, including reports on recruitment, enrollment, retention, and adverse events

Supervise and manage recruitment, contacting and building working relationships with primary providers in the community

Contribute to the coordination and writing of grants and manuscript submissions for the Unit

Plan for Unit staffing needs which may include hiring and training of research associates and clinical staff as needed

Perform other related duties as required

Qualification

Master's in Public HealthQualitative research methodsClinical PracticeData managementSupervising research staffPhlebotomy certificationInterpersonal skillsOrganizational skillsCommunication skillsAttention to detail

Required

Master's in Public Health or other relevant Master's level degree

3+ years conducting/coordinating studies in public health, medical, substance abuse, or social services fields

Experience with qualitative research methods and analyzing qualitative data

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

Experience supervising and managing research staff

Experience with diverse communities, particularly communities of color, LGBTQ, and substance using communities

Experience managing and analyzing data in Microsoft Access, Excel and/or Stata is a plus

Proven high-level of attention to detail and ability to function independently and perform multiple critical tasks simultaneously under dynamic circumstances and competing deadlines

Familiarity with research processes including protocol development, recruitment, quantitative and qualitative research methods, data management, regulatory submissions, and quality assurance monitoring

Strong interpersonal and communication skills (both verbal and written)

Excellent organizational skills

Proficient computer skills including experience with Word, Excel, EndNote and PowerPoint

Proficiency in data management (REDCap, Excel, Atlas.ti) and/or computer coding experience

Knowledge of HIV prevention and harm reduction principles

Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects and confidentiality of research records

Phlebotomy certification