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Senior Clinical Research Associate (Senior Cra)

Prorelix Research
ProRelix Research
3-5 years
preferred by company
Boston, Massachusetts, United States
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Job Title: Senior Clinical Research Associate (Senior CRA)

Location: Boston, Massachusetts, USA
Job Type: Full-Time
Experience Required: 3–5 Years (Freshers are not eligible)
Industry: Clinical Research / Pharmaceuticals / Biotechnology / Healthcare
Work Model: On-site / Hybrid / As per company policy

About the Role
We are looking for a highly motivated and detail-oriented Senior Clinical Research Associate (Senior CRA) to join a dynamic clinical research team in Boston, USA. This role is ideal for experienced clinical research professionals with strong expertise in clinical trial monitoring, site management, regulatory compliance, and stakeholder coordination.

The Senior Clinical Research Associate will play a critical role in ensuring clinical studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), regulatory requirements, and company quality standards. This position requires hands-on experience in managing trial sites, monitoring study progress, and maintaining high standards of data integrity and patient safety.

Key Responsibilities

Clinical Trial Monitoring & Site Management

  • Conduct on-site, remote, and hybrid monitoring visits for assigned clinical trials.
  • Oversee site initiation, routine monitoring, interim visits, and close-out activities.
  • Ensure clinical sites adhere to study protocols, regulatory requirements, and sponsor expectations.
  • Assess site performance and proactively identify operational risks or compliance concerns.

Regulatory Compliance & Quality Assurance

  • Ensure all trial activities comply with ICH-GCP guidelines, FDA regulations, SOPs, and applicable local regulations.
  • Review essential regulatory documentation and maintain Trial Master File (TMF) accuracy.
  • Verify informed consent documentation, protocol adherence, and subject safety reporting compliance.
  • Support audit readiness, inspection preparation, and quality assurance activities.

Data Verification & Clinical Documentation

  • Perform source data verification (SDV) and source document review (SDR).
  • Ensure clinical data accuracy, completeness, and timely reporting within study timelines.
  • Collaborate with data management teams to resolve discrepancies and data queries efficiently.
  • Track enrollment, protocol deviations, adverse events, and site performance metrics.

Site Relationship Management

  • Build strong working relationships with investigators, site coordinators, and research teams.
  • Provide guidance and training to site personnel on study procedures and compliance expectations.
  • Serve as a key communication bridge between sponsor, CRO, and clinical sites.

Cross-Functional Collaboration

  • Work closely with clinical operations, regulatory affairs, medical monitoring, pharmacovigilance, and project management teams.
  • Support study timelines, recruitment strategies, and milestone achievement.
  • Participate in study meetings, site discussions, and project planning activities.

Risk Management & Problem Resolution

  • Identify site-level risks and implement mitigation strategies proactively.
  • Escalate significant issues related to compliance, patient safety, enrollment, or protocol deviations.
  • Contribute to continuous improvement initiatives for monitoring processes and study execution.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Biomedical Sciences, or a related field.
  • 3–5 years of hands-on experience in clinical research monitoring or Clinical Research Associate roles.
  • Strong understanding of ICH-GCP, FDA regulations, clinical trial processes, and regulatory compliance standards.
  • Proven experience managing clinical trial sites independently.
  • Experience in pharmaceutical, biotechnology, CRO, or healthcare research environments preferred.
  • Strong written and verbal communication skills with excellent documentation accuracy.
  • Ability to travel for site visits as required.