Job Description

Job Description

Job Description

Description:

Job Summary

The Senior Research Assistant (Senior RA) supports participant-facing implementation of the CNICS cohort study at The Fenway Institute. This NIH-funded, multi-site observational cohort study collects longitudinal behavioral, clinical, and biological data from people living with HIV. The Senior RA will lead recruitment and retention efforts in a medical setting, manage specimen processing (including PBMC isolation and cell pellet preparation) and oversee regulatory documentation, procurement, and study financial operations.

The Senior Research Assistant is a key member of the CNICS implementation team, responsible for leading daily study operations at the site level. While working under the direction of the CNICS Research Manager, the Senior RA operates with a high level of autonomy in managing regulatory documentation, procurement, data tracking, and participant engagement. This role is ideal for candidates looking to deepen their experience in NIH-funded cohort research, regulatory operations, and the integration of research within clinical care settings.

Key Responsibilties:

Participant Engagement and Study Visits

• Recruits and engages eligible participants during clinical visits, in coordination with providers and research staff
• Conducts informed consent and behavioral assessments in a respectful, affirming, and research-compliant manner
• Administers and monitors completion of electronic patient-reported outcomes (ePROs), ensuring timely data capture for CNICS and add-on studies
• Uses EMR systems and CNICS-specific flags to identify eligible participants in real time
• Maintains participant confidentiality in accordance with IRB and HIPAA standards
• Supports participant retention strategies across in-person and remote workflows
• Communicates select results (e.g., lab findings) to providers or participants as appropriate and per study policy

Regulatory Compliance & Oversight

• Serves as the lead staff member responsible for maintaining study regulatory files across multiple CNICS-related protocols
• Prepares and submits IRB applications, amendments, and continuing reviews with minimal oversight
• Ensures that all required regulatory documentation (e.g., consent forms, protocol logs, CVs, training records) is complete, current, and audit-ready
• Coordinates with Fenway’s regulatory team and CNICS Core staff to ensure compliance with NIH, institutional, and site-specific requirements
• Conducts routine quality checks of regulatory documentation and tracks protocol deviations, adverse events, and reportable occurrences
• Supports implementation of CNICS add-on studies and ensures regulatory readiness for supplemental protocols and modules

Procurement & Financial Coordination

• Manages day-to-day study financial operations, including purchasing lab supplies, obtaining quotes (e.g., for pipette calibration, specimen materials such as fetal bovine serum), and coordinating with vendors
• Tracks and reconciles participant compensation, including issuing and managing ClinCards, ensuring timely payment, and maintaining detailed logs
• Collaborates with grants and finance teams to ensure purchases and payments align with study budgets and institutional policies
• Prepares and submits reimbursement and invoice documentation for study-related activities and participant visits
• Maintains organized records of all transactions, expenses, and vendor communications to support audits and financial tracking

Specimen Processing & Laboratory Coordination

• Independently processes biological specimens, including PBMC isolation and cell pellet preparation
• Prepares, packages, and ships specimens to the CNICS central lab or study partners in accordance with IATA regulations and study protocols
• Maintains inventory of biospecimen collection kits and lab supplies; requests resupply as needed
• Calibrates and maintains equipment; follows all biosafety and lab safety procedures
• Coordinates with the CNICS central lab to resolve discrepancies and ensure specimen integrity
• Ensures all biospecimen logs are complete, accurate, and aligned with data capture timelines

Study Coordination & Data Collection

• Supports data entry, tracking, and quality checks in REDCap and CNICS-specific systems
• Monitors enrollment and retention metrics and prepares reports as needed
• Collaborates with national partners on sub-studies, protocol updates, and site-level implementation
• Proactively identifies challenges in recruitment or data quality and proposes process improvements
• Coordinates internal study meetings, documentation, and communications with research collaborators

Perform Related Duties as Assigned

Requirements:

· Bachelor’s degree required.

· Minimum 2 years of experience in human subjects research

· Strong familiarity with NIH-funded research, IRB processes, and regulatory documentation for observational studies

· Prior experience with specimen processing, including PBMC isolation and cell pellet preparation

· Familiarity with EMR systems (e.g., EPIC), REDCap, and secure data management workflows

· Demonstrated ability to work independently and manage shifting priorities

· Strong communication and organizational skills; able to coordinate across clinical and research teams

· Ability to 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.

· 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

· Master’s degree or equivalent experience preferred (e.g., public health, biology, psychology)

· Experience with multi-site longitudinal cohort studies strongly preferred

· Experience working with LGBTQ+ individuals, persons living with HIV, and/or BIPOC communities strongly preferred

This is a union position in a Fenway Health bargaining unit represented by 1199 SEIU United Healthcare Workers East.

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 11 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.

Job Tags

Holiday work, Shift work,

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