Clinical Research Program Manager

Location
San Francisco, California
Posted
Jan 26, 2021
Closes
Feb 25, 2021
Degree Level
Masters
Willingness to Travel
up to 25%
Experience Level
Management

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. The Center on Substance Use and Health conducts pharmacologic and behavioral interventions, observational studies, and related activities to maximize the health outcomes of people 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 progress and regulatory affairs. You must be willing to work in a team and enjoy problem-solving, as our studies are generally investigator-initiated and require in-house development of resources. This posting specifically covers studies addressing opioid use and overdose.

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

 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
  • Provide operational, clinical, and project management oversight for assigned research
  • Coordinate concurrent research studies, which may include pharmacologic and/or multi-site trials
  • Provide team with guidance regarding study design and logistics; implement structural changes to maximize time efficiency within the constraints of limited resources
  • 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; provide guidance and mentorship as a supervisor; conduct regularly scheduled supervisory meetings with direct reports and performance evaluations
  • 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 Center 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
  • Ensure research personnel collect data and perform assessments in a standardized fashion consistent with study protocol
  • Design comprehensive tracking systems for monitoring progress of research participants and activities
  • Independently manage regulatory affairs and ensure regulatory compliance 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; coordinate staff work schedules
  • Oversee Unit-level responsibilities and strategic planning of Unit needs
  • Travel to other study sites for training
  • Perform other related duties as required

JOB 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 abuse, or social services fields
  • 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
  • Fluency in the usage of Committee of Human Research (CHR) online iMedRIS system for submission, renewal, and modification of protocols
  • Experience supervising, managing, and training research staff
  • Experience with diverse communities, particularly communities of color, LGBTQ, and substance using communities. Understanding of patient population to create rapport, while also giving insight to what is realistic and appropriate for patient participation
  • Experience managing and analyzing data in Microsoft Access, Excel, Stata, or related programs
  • Experience with dissemination and presentation of research findings to broad audiences

    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 (MS Access, SQL, Visual Basic, REDCap) 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
  • Knowledge of and experience with managing federal grant budgets
  • Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation
  • Familiarity with medical terminology and experience with electronic medical records
  • Demonstrated ability to work collaboratively with multidisciplinary team with a wide range of educational backgrounds

  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

APPLICATION PROCEDURE

Interested applicants should submit a cover letter and resume for consideration.

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.

Please apply at the following URL: https://recruiting2.ultipro.com/PUB1001PUBH/JobBoard/6705aa07-0bcb-4660-ad1b-2fda952becc7/OpportunityDetail?opportunityId=6c678744-3cfd-4703-9c81-170d5225142e

 

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