Senior Research Assistant, Data Studies

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 implem