Under the direction of The Fenway Institute's Associate Medical Director and the Clinical Research Operations Manager, the Study Coordinator will work with staff in the BioMedical Research Program at The Fenway Institute to support and implement clinical trials funded by a government agencies and/or industry sponsors.

Please note that TFI works on multiple projects and within your job function, you may be assigned to different or multiple projects at various times.

Responsabilities:

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
• Act as the point-person to direct internal and external support teams (e.g., regulatory, finance, clinical, etc.) in their work on assigned projects
• 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 start-up and site monitoring visits for assigned projects
• 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 including:
• Study recruitment and retention efforts
• Scheduling of participant visits for in-person and/or remote visits
• Backup support for running study visits
• Collect research data according to study protocols
• Collection and processing of study samples, if relevant
• Supports individual and group intervention session delivery

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

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 authorship of academic articles and poster presentations analyzing and describing study data as required

Manages Relationship with study sponsor and investigators

• Maintains regular communication with project 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.

Meets Agency Participatory Expectation

• Adheres to all agency and departmental policies and procedures
• Participates in quality assessment and improvement activities as requested
• Adheres to the highest principles of patient and client confidentiality
• Adheres to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
• Attends all required meetings and professional trainings
• Maintains professional competence necessary to perform job responsibilities; maintain and provides agency with records of continuing education activities
• Serves on agency committees and in professional organizations when requested

• At least two years of clinical research experience
• Experience with blood collection (phlebotomy) procedures, or willingness to learn, as applicable
• 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
• 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

Preferred Qualifications

• Bachelor's degree or higher in a field related to social science or epidemiology research
• 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
• 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

This position is fully or partially grant-funded and is therefore contingent upon the continued receipt of these funds. Grant-funded positions will end with the culmination of the grant. Should the funding be extended or other new funding received, the position may be extended at the discretion of Fenway Health.

Physical Requirements:

• Ability to meet the following physical requirements with or without reasonable accommodations:
• Sit at a computer station for extended periods of time
• Ability to type on a keyboard for extended periods of time

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.