Study Coordinator

Posted: 11/21/2022

Under the direction of Principal Investigator, Dr. Sari Reisner, and the Clinical Research Operations Manager, the Study Coordinator works with staff in the Epidemiology Research Program at The Fenway Institute to support and implement clinical trials according to specified study protocols. The primary study this position will work on is a federally-funded HIV prevention trial of peer-delivered strategies with transgender men and people of transmasculine experience. Specific tasks this role performs are listed below.

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1. Coordinates Research Studies and Associated Tasks 

  • Oversees the implementation of study project workflow, timelines, and study resource needs to ensure efficient and high-quality work is performed
  • Ensures study staff and procedures are in compliance with the regulatory management guidelines of the study sponsor, The Fenway Institute, and other involved parties
  • Leads study initiation and site monitoring visits
  • Reviews and implements quality improvement measures
  • Actively participates on all study-related conference calls and attends study specific operations meetings and trainings.
  • Plans and leads study-specific operations team meetings and trainings
  • Develops and implements recruitment plans for studies.
  • Meets regularly with study staff to review adherence to the project design, conduct of the project, staffing issues, and the fidelity and quality assurance of the interventions
  • Troubleshoots study issues, interfaces with and solves problems raised by sponsors, funders, collaborators and staff
  • Works with Research Associate and other study staff in general study operations

2. Provides supervision and training to assigned staff

  • Provides administrative/operational supervision and training for staff working on assigned projects, as needed
  • Assists in developing and coordinating orientation for new staff to support knowledge transfer of research process and regulations.
  • Serves as a backup resource if designated study staff are absent to ensure study procedures occur with minimal interruptions

3. Manages data collection, dissemination and quality

  • Reviews project-specific systems and designs, and implement new systems to ensure and enhance project efficiency
  • Maintains complete documentation of all quality management activities
  • Oversees collection and dissemination of data necessary to report adverse events to the study team and sponsor
  • Assists in the authorship of academic articles and poster presentations analyzing and describing study data as required

4. Manages Relationship with study sponsor and investigators

  •  Maintains regular communication with project principal investigators and co-investigators and collaborators
  • Develops and disseminates reports pertaining to recruitment, enrollment, retention, serious adverse events and other critical study information to the study PI and other key staff
  • Supports managements of logistics of study team meetings and conference calls
  • Manages and completes other tasks related to projects as needed

5. Meets Agency Participatory Expectation

6. Other duties as assigned

 

Requirements

 

  • Experience with blood collection (phlebotomy) procedures, or willingness to learn, as applicable
  • Willingness to supervise other staff members
  • Ability to work harmoniously and effectively with colleagues, research participants, patients, clients and vendors across the spectrum of diversity, including but not limited to race, ethnicity, color, gender identity, sexual orientation, age, socio-economic status, national origin and immigrant status, religious or spiritual identity, disability (physical, mental, emotional and developmental), veteran status, HIV status, and/or limited English proficiency
  • Willingness to contribute towards Fenway’s efforts in becoming an anti-racist organization and promoting a culture dedicated to ongoing development in service of humility, equity, diversity, inclusion, and belonging, where differences are acknowledged and valued

Preferred Qualifications

  • Bachelor’s degree or higher in a field related to social science or epidemiology research
  • At least two years of clinical and/or behavioral research experience highly desirable
  • Has lived experience as a transgender man, transmasculine person, or gender diverse community member
  • Familiarity working to address LGBTQIA+ community needs, with emphasis on working with transgender and gender diverse communities
  • Experience working in the field of HIV and sexual health education and screening with diverse, at-risk populations
  • Familiarity with quantitative and/or qualitative research methods and software
  • Detail-oriented and competent multi-tasking
  • Strong problem-solving skills; able to solve problems collaboratively as part of a team
  • Excellent communication and interpersonal skills
  • Receptive to training and feedback
  • Manages stress effectively
  • Critical thinker – able to anticipate shortfalls and plan ahead
We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 12 paid holidays, paid vacation, and more. LGBTQIA+ identified persons, Black, Indigenous, and other people of color (BIPOC), and individuals from other historically underrepresented communities are strongly encouraged to apply.Highly experienced individuals may be compensated at a higher rate.

Internal ID: TFI-23-FT-15