Heluna Health invites applications for the full-time position of Clinical Research Program Manager in the Center on Substance Use and Health (CSUH) at the San Francisco Department of Public Health. CSUH conducts pharmacologic and behavioral interventions, observational studies, and related activities to maximize the health outcomes of people who use alcohol, methamphetamine, opioids, and other substances. We work with people who are actively using substances, and focus on meeting their goals related to their substance use, including reduction in use or harms, prevention or treatment of infectious diseases, or prevention of drug overdose. We conduct research in a community-based environment in downtown San Francisco, with the facilities and resources needed to perform complex clinical research studies (suite of exam rooms, alarmed pharmacy for medication trials, and on-site CLIA-waived laboratory). We are proud to treat people who use substances with respect and dignity and enjoy a close-knit culture of intellectual curiosity, collaboration, and fun.
In the position of Clinical Research Program Manager, you work under the supervision of the Director, and are responsible for overseeing study day-to-day activities, progress, and regulatory affairs. You must have good attention to detail, be willing to work in a team, and enjoy problem-solving, as our studies are usually investigator-initiated and require in-house development of resources.
This is a temporary, grant-funded, Full time, benefited position. Employment is provided by Heluna Health.
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)
Pay Range: $79,500 - $87,500 annually
Interested applicants should submit a cover letter AND resume for consideration.
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; and supporting 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)
•Facilitate weekly meetings and supervise research associates and other staff working on studies; conduct regularly scheduled supervisory meetings with direct reports, complete performance evaluations, and provide guidance and mentorship as a supervisor
•Ensure that study staff are up-to-date with all training requirements, licenses and certifications
•Plan for and manage study data needs, including creation and modification of survey instruments, interview guides, case report forms, tracking databases, etc.
•Manage quality control systems for research records, study data, and regulatory obligations, ensuring data are collected in a standardized fashion consistent with the study protocol
•Manage regulatory affairs and ensure regulatory compliance of studies, including Institutional Review Board (IRB), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Data Safety Monitoring Board, Food and Drug Administration (FDA), and/or other funding or regulatory agency reports
•Generate as-needed reports for study team, including reports on recruitment, enrollment, retention, and adverse events
•Plan for staffing needs, including hiring and training of research associates and clinical staff as needed; coordinate staff work schedules
•Other related duties as required
MINIMUM QUALIFICATIONS
Education/Experience
•Master's in Public Health or other relevant Master's level degree
•5 years conducting/coordinating studies in public health, medical, substance use, or social services fields
•Experience applying regulations and guidelines such as the Protection of Human Subjects through IRB regulations, Good Clinical Practice Guidelines, and Health Insurance Portability and Accountability Act (HIPAA)
•Experience writing detailed reports or IRB submissions
•Experience supervising, managing, and training staff
•Experience with diverse communities, particularly communities of color, LGBTQ, and/or substance using communities
•Experience managing data in Microsoft Access, Excel, Stata, or related programs
Other Skills, Knowledge, and Abilities
•Proven high-level of attention to detail and ability to function independently and perform multiple tasks simultaneously under dynamic circumstances
•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 (e.g., MS Access, REDCap) and/or some computer coding experience preferred
•Knowledge of HIV prevention and harm reduction principles
•Comfort with medical terminology and experience with electronic medical records
•Demonstrated ability to work collaboratively with multidisciplinary team with a wide range of educational backgrounds
•Experience with dissemination and presentation of research findings to broad audiences
PHYSICAL DEMANDS
Stand Frequently
Walk Frequently
Sit Frequently
Handling / Fingering Constantly
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 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)