Senior Study Coordinator/Investigator-Initiated Studies

Description

Heluna Health invites applications for one full-time position of Senior Study Coordinator, Investigator-initiated studies (IDS). Bridge HIV is a grant-funded research unit affiliated with the San Francisco Department of Public Health and the University of California San Francisco. Bridge HIV has been searching for new and innovative ways to fight HIV/AIDS since the onset of the epidemic in the early 1980s. The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods. In response to the COVID-19 pandemic, Bridge HIV has also been conducting COVID-19 vaccine and epidemiology studies. For more information, please see www.bridgehiv.org.

Under the direct supervision of the Clinical Research Director, the Senior Study Coordinator, Investigator-initiated studies (IDS) will help coordinate, facilitate, and manage the overall implementation of studies evaluating strategies to support the successful uptake and adherence to HIV prevention and treatment interventions (e.g. oral and injectable PrEP, injectable HIV treatment). This position will be part of a dynamic team conducting multiple HIV prevention studies.

This is a temporary, grant-funded, full-time, benefitted position. Employment is provided by Heluna Health. Some weekend and evening work may be required.
This is an on-site position that excludes remote work.

Pay rate: $127,682 annually

Applicants must submit a cover letter and resume to be considered.

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).

ESSENTIAL FUNCTIONS
• Work with a high level of autonomy to provide overall coordination of investigator-initiated studies as well as ancillary network projects
• Create and track milestones and timelines to ensure successful implementation and conduct of studies
• Serve as primary liaison with technology vendors to develop online and mobile health tools
• Develop and implement study specific protocols and a comprehensive quality assurance and control plan
• Design informed consent documents, study form-sets and case report forms, and a plan for screening and recruitment of study participants
• Provide comprehensive trainings for partner study sites on study procedures and provide overall coordination for sites during all phases of study implementation
• Independently manage day-to-day study activities to ensure prompt responses to study participants by study staff
• Assist research associates and clinicians with telephone support calls with study participants
• Oversee protocol compliance; recognize, track, and report protocol deviations/violations and adverse events per protocol requirements; ensure ethical standards of research are followed
• Coordinate communication with study sponsor, research collaborators, and other stakeholders
• Participate actively in protocol team meetings and conference calls
• Develop educational materials and educate the community regarding studies and research-related issues
• Prepare regulatory submissions and handle routine regulatory activities
• Provide oversight of laboratory issues, specimen processing, ordering of supplies, home test kit inventory management, and scheduling issues
• Create and maintain data collection forms, logs, and databases
• Perform data entry of study data
• Create weekly reports on study recruitment, retention, and other monitoring measures
• Provide administrative support to study teams, including formulating agendas, recording of minutes, and determining action items following meetings
• Work with directors and PIs to resolve problems as they arise

Management and Leadership
• Assists with creating and implementing the Bridge HIV Racial Equity A3 (Racial Equity Action Plan)
• Evaluate the importance and urgency of problems; analyze complex and non-routine issues offering innovative solutions
• Develop project plans/schedules and motivate team to meet deadlines
• Interpret and apply policies and regulations
• Supervise the IDS Program Assistant and Research Associates
• Organize regular supervisory meetings with direct reports
• Conduct annual performance reviews and develop work performance plans as needed.
• Provide disciplinary reviews/counseling when necessary
• Assess staff training needs and devise personalized training plans to ensure work is up to organizational standards
• Promote teamwork and foster a cohesive and effective work environment
• Contribute actively to a cohesive team environment
• Foster innovation, open and clear communication, and collaboration that promotes excellence

Organizational Meetings and Working Groups
• Participate in weekly IDS team meetings, weekly all-staff meetings, recruitment strategy meetings, cross-team “Hub” meetings, and Managers Meetings
• Assist with creating agendas, facilitating discussion and identifying action items at IDS team meetings
• Participate in Bridge HIV standing and ad hoc working groups

NON-ESSENTIAL FUNCTIONS
• Other duties as assigned

JOB QUALIFICATIONS

MINIMUM QUALIFICATIONS
• Demonstrates strong commitment to anti-racism and health equity
• A level of education or training equivalent to a Master's degree in a related health discipline or a minimum of two (2) years of experience providing coordination, oversight, or management of a research study or similar program.
• Intermediate to advanced knowledge of a variety of computer software programs, including word processing, spreadsheet, database applications (e.g. Microsoft Access), RedCAP, Qualtrics, email and internet.
• Extremely organized with close attention to detail in a work setting.
• Strong oral/written communications skills and interpersonal/listening skills.
• Willingness and ability to work as part of a collaborative team.
• Experience working with ethnically, culturally, and sexually diverse populations.
• Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects and confidentiality.
• Knowledge of regulatory procedures including IRB submissions, renewals, and revisions.
• Knowledge of HIV/STD prevention with a focus on harm reduction.

DESIRED QUALIFICATIONS
• Fluency in Spanish.
• Previous experience in biomedical clinical research
• Experience supervising staff

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
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.