Research Study Coordinator

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: $79500-$87500 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
Masters in Public Health or other relevant Masters 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 ) 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 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.

EEOC STATEMENT
It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants without regard to age (40 and over) national origin or ancestry race color religion sex gender sexual orientation pregnancy or perceived pregnancy reproductive health decision making physical or mental disability medical condition (including cancer or a record or history of cancer) AIDS or HIV genetic information or characteristics veteran status or military service.

Required Experience:

IC