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Research Study Coordinator
Research Study CoordinatorHeluna Health • San Francisco, CA , USA
Research Study Coordinator

Research Study Coordinator

Heluna Health • San Francisco, CA , USA
30+ days ago
Job type
  • Full-time
Job description

Heluna Health invites applications for the full-time position of Research Study

Coordinator in the Center on Substance Use & Health (CSUH), a grant-funded research unit within the San Francisco Department of Public Health (SFDPH). Research in this Unit focuses on the evaluation of behavioral, biological, and pharmacological clinical trials to reduce harms from substance use risk behaviors. Our close-knit team consists of a Medical Director, Senior Research Scientist, Research Study Coordinator, Research Clinicians, Clinical Psychologist, Research Associates and Recruitment Team.

This is a temporary, grant-funded, Full time, benefitted position. Employment is provided by Heluna Health.

Salary Range : $79,500-$87,500 annually

Interested individuals must submit a cover letter and resume for consideration. Applications without a cover letter will not be considered.

ESSENTIAL FUNCTIONS

  • 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
  • JOB QUALIFICATIONS

    Education / Experience

  • 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
  • Other Skills, Knowledge, and Abilities

  • 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
  • PHYSICAL DEMANDS

    Stand Frequently

    Walk Frequently

    Sit Frequently

    Handling / Fingering Occasionally

    Reach Outward Occasionally

    Reach Above Shoulder Occasionally

    Climb, Crawl, Kneel, Bend Occasionally

    Lift / Carry Occasionally - Up to 50 lbs

    Push / Pull Occasionally - Up to 50 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,

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