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Senior Clinical Research Associate

3+ years
Not Disclosed
10 Oct. 9, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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💼 Position: Senior Clinical Research Associate

📍 Location: Bangalore, India
🧪 Department: Clinical Research
🕓 Employment Type: Full-Time


🔹 Job Summary

We are seeking a Senior Clinical Research Associate (CRA) to join our expanding clinical research team. The ideal candidate will ensure clinical trials are conducted in compliance with ICH-GCP guidelines, local regulations, and company SOPs, contributing to the highest standards of clinical excellence.


🔹 Key Responsibilities

  • Work in accordance with ICH E6 (GCP) principles and applicable SOPs.

  • Conduct feasibility assessments and support project setup activities.

  • Perform site selection, investigator/site contract negotiation, and facilitate contract execution.

  • Develop and locally adapt study-specific documentation.

  • Set up and maintain the Trial Master File (TMF).

  • Facilitate regulatory submissions in collaboration with relevant teams.

  • Prepare for, conduct, and participate in Investigator Meetings.

  • Conduct site initiation, monitoring, and closeout visits.

  • Maintain effective communication with study teams, investigators, clients, and vendors.

  • Support the Project Manager (PM) or Project Team Lead (PTL) with project updates and issue resolution.

  • Manage CRF retrieval, ensure timely query resolution, and assist with project closeout.

  • Participate in client meetings, teleconferences, and cross-functional discussions.


🔹 Desired Skills & Experience

  • Minimum 3 years of on-site monitoring experience.

  • Strong working knowledge of Good Clinical Practice (GCP) and local regulatory requirements.

  • Excellent communication and organizational skills.

  • Ability to manage multiple sites and projects efficiently.


🎓 Education

  • Bachelor’s or Master’s degree in Life Sciences or a related field.