Work Location: Hybrid (remote and in-person work expected in Boston MA area)
Expected Schedule: 15 hours a week within a usual Monday-Friday first shift schedule. May require occasional flexible working schedule with some evening and weekend hours.
Function
This position sits within The Fenway Institute (TFI) the research education and policy department of Fenway Health. Reporting to the Assoc. Director of Research Operations and under the supervision of the Principal Investigator and other TFI Leadership the Research Associate supports the implementation of research studies.
Position Funding
This position is grant-funded and is dependent on the availability of continued grant support for the assigned study/studies. It is possible that the employees effort will be transitioned in whole or in part to other research studies as needed.
Representative Duties
Study Preparation and Administrative/Outreach Implementation
- Assist with study startup: Help prepare study documents (e.g. protocols consent forms case report forms participant files regulatory binders and visit checklists).
- Regulatory compliance: Ensure studies meet regulatory requirements (e.g. IRB submissions informed consent documentation).
- Participant recruitment: Implement study recruitment efforts that lead to study participation with responsibilities such as reviewing records identifying and establishing recruitment opportunities and initiating outreach to prospective research participants attending community events; creating recruitment materials; and maintaining recruitment and screening calendars databases and study documentation.
Participant Interaction and Data Collection
- Obtain informed consent: Explain study procedures and risks/benefits to participants.
- Conduct study visits: Schedule study visits and maintain study calendar/visit spreadsheets. Confirm participant eligibility and assist with or perform tasks like administering surveys scheduling follow-ups and accurately and comprehensively completing visit notes data collection instruments case report forms etc.
- Monitor participant safety: Report non-compliance adverse events or unanticipated problems promptly to the research leads.
Data Management and Documentation
- Maintain accurate records: Ensure timely and accurate entry of data into study files including paper files and electronic databases (e.g. REDCap EDC systems) and keep organized and complete source document files including signed consent forms case report forms and lab reports.
- Assist in data cleaning and audit preparation: Monitor the quality of collected data through routine and ad hoc quality assurance and quality improvement activities (e.g. record review monitor visit preparation completion of visit checklists) and respond to data queries.
- Use best research practices as defined by Good Clinical Practice (GCP) TFI standard operating procedures study specific procedures and the research protocol and follow all established guidelines of confidentiality and ethical accountability.
Communication and Collaboration
- Liaise with internal and external teams: Communicate with investigators sponsors IRBs and study monitors. Share study information to Fenway Health staff patients and community.
- Attend team and departmental meetings: Provide updates and help resolve logistical or compliance issues.
- Support training and onboarding: Help train new research assistants or interns on study protocols and procedures
Administrative and Logistical Support
- Manage supplies and equipment: Track maintain and order study-specific materials.
- Schedule appointments and organize calendars: Coordinate participant visits and team availability.
- Assist with study closeout: Ensure all documents are archived according to protocol and regulatory guidelines.
- Assist in the development of research projects and publication/dissemination of study findings: Utilize library and electronic databases to locate and obtain research articles and performs administrative duties as needed in the development of research proposals or manuscripts.
- Develop and share understanding of research context: Monitor and track institutional state level and federal level policies impacting participant population and research; develop knowledge of field by completing pertinent trainings attending didactics reading academic journals articles and other relevant publications attending conferences seminars forums trainings and other presentations.
Other related duties as required.
Meets Agency Participatory Expectations
- Adheres to all agency and departmental policies and procedures
- Identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
- Attends all required meetings in-services and professional trainings
- Maintains professional competence necessary to perform job responsibilities; maintains and provides agency with records of continuing education activities
- Serves on agency committees and in professional organizations when requested
- Work harmoniously and effectively with colleagues 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 and/or limited English proficiency.