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Senior Clinical Research Associate (Senior Cra)

Prorelix Research
ProRelix Research
3-5 years
preferred by company
Pune, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Job Title: Senior Clinical Research Associate (Senior CRA)

Location: Pune, Maharashtra, India
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 seeking an experienced and highly organized Senior Clinical Research Associate (Senior CRA) to join a growing clinical research team in Pune, India. This role is ideal for professionals with proven expertise in clinical trial monitoring, site management, regulatory compliance, and stakeholder coordination within pharmaceutical, biotechnology, CRO, or healthcare research environments.

The Senior Clinical Research Associate will be responsible for overseeing clinical trial execution, ensuring study sites maintain compliance with protocol requirements, regulatory standards, and Good Clinical Practice (GCP) guidelines while supporting high-quality and timely clinical research delivery.

Key Responsibilities

Clinical Trial Monitoring & Site Oversight

  • Conduct site initiation visits (SIV), routine monitoring visits, interim monitoring, remote monitoring, and close-out visits for assigned clinical studies.
  • Ensure clinical trial sites adhere to approved study protocols, sponsor requirements, and regulatory obligations.
  • Evaluate site performance, enrollment progress, data quality, and protocol compliance.
  • Monitor patient safety reporting, study conduct, and documentation completeness.

Regulatory Compliance & Quality Management

  • Ensure compliance with ICH-GCP guidelines, CDSCO regulations, SOPs, and global clinical research standards.
  • Review essential regulatory documents, informed consent forms, and site documentation for completeness and accuracy.
  • Support audit readiness, sponsor inspections, and quality assurance activities.
  • Track protocol deviations and ensure timely corrective actions where required.

Source Data Verification & Data Review

  • Perform source data verification (SDV), source document review (SDR), and clinical data quality assessments.
  • Collaborate with data management teams to resolve queries, inconsistencies, and documentation gaps.
  • Ensure study data integrity, accuracy, and timely reporting.

Site Relationship Management

  • Build strong professional relationships with principal investigators, site coordinators, hospital staff, and study stakeholders.
  • Provide training and operational guidance to site teams on protocol requirements and compliance expectations.
  • Act as the primary liaison between sponsor/CRO teams and research sites.

Cross-Functional Collaboration

  • Work closely with clinical operations, medical affairs, regulatory teams, pharmacovigilance, project management, and data management stakeholders.
  • Support study milestone achievement, recruitment strategies, and issue resolution.
  • Participate in internal and external clinical project meetings.

Risk Management & Problem Solving

  • Identify operational, compliance, and patient safety risks proactively.
  • Escalate critical issues and support implementation of mitigation strategies.
  • Contribute to process improvement initiatives that enhance monitoring quality and study efficiency.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, Nursing, or a related healthcare discipline.
  • 3–5 years of relevant experience as a Clinical Research Associate or in clinical monitoring roles.
  • Strong knowledge of ICH-GCP, clinical trial operations, protocol compliance, and regulatory requirements.
  • Experience in pharmaceutical, biotechnology, CRO, or hospital-based clinical research environments preferred.
  • Strong documentation, analytical, communication, and stakeholder management skills.
  • Ability to travel for site monitoring visits when required.

Preferred Skills

  • Clinical trial monitoring
  • Source data verification (SDV)
  • Site management
  • Protocol compliance
  • Regulatory documentation review
  • Trial Master File (TMF) handling
  • Risk-based monitoring
  • Clinical operations coordination
  • Stakeholder communication
  • Audit and inspection readiness