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Senior Clinical Research Associate (Senior Cra)

Navitas Lifesciences
Navitas lifesciences
3+ years
preferred by company
Bangalore, India
1 May 18, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: 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

Senior Clinical Research Associate (Senior CRA)

Job Type: Full-Time
Work Mode: Onsite / Hybrid / As Per Business Requirement
Industry: Clinical Research | CRO | Pharmaceutical | Life Sciences | Clinical Trials
Experience Required: Minimum 3+ Years of Clinical Monitoring Experience (Freshers Not Eligible)

Job Overview

A growing clinical research organization is seeking an experienced Senior Clinical Research Associate (Senior CRA) to support end-to-end clinical trial execution and site management activities. This opportunity is ideal for professionals with strong expertise in clinical monitoring, site management, regulatory submissions, investigator coordination, GCP compliance, TMF management, and clinical operations.

The selected candidate will play a critical role in managing clinical trial sites, ensuring protocol compliance, supporting project management teams, and maintaining strong communication between sponsors, sites, investigators, and cross-functional stakeholders.

This role is ideal for professionals looking to advance their careers in clinical trial management, clinical monitoring, site operations, and global clinical research execution.

Key Responsibilities

Clinical Trial Start-Up & Study Set-Up

  • Conduct feasibility assessments for study execution and site suitability.
  • Support project start-up activities and operational planning.
  • Perform site selection and qualification visits for clinical trial sites.
  • Facilitate investigator/site contract negotiation and execution.
  • Develop and locally adapt study-specific documentation.
  • Support regulatory submission activities and essential study approvals.
  • Set up and maintain the Trial Master File (TMF).

Clinical Monitoring & Site Management

  • Conduct:
    • Site Initiation Visits (SIV)
    • Routine Site Monitoring Visits
    • Site Close-Out Visits
  • Monitor clinical trial progress in accordance with:
    • ICH E6 Good Clinical Practice (GCP) Guidelines
    • Applicable SOPs
    • Local regulatory requirements
  • Ensure site compliance with study protocols, data quality standards, and regulatory expectations.
  • Maintain continuous communication with investigators, study coordinators, and site teams.

Project Execution & Clinical Operations Support

  • Support overall project conduct and operational execution.
  • Assist Project Managers (PM) and Project Team Leads (PTL) with project updates and issue tracking.
  • Participate in investigator meetings, sponsor meetings, teleconferences, and internal operational reviews.
  • Act as backup communication support between clients, vendors, and project teams when required.

Data Management & Query Resolution

  • Support Case Report Form (CRF) retrieval and documentation completeness.
  • Ensure timely query resolution and site-level data clarification.
  • Maintain accurate trial documentation and essential records.

Issue Management & Escalation

  • Identify and resolve site-level operational challenges.
  • Escalate critical issues to Project Managers or clinical leadership where necessary.
  • Support risk mitigation and trial continuity planning.

Trial Close-Out Activities

  • Conduct project closeout activities and site closure procedures.
  • Ensure all essential documentation is completed, reconciled, and archived.
  • Support final trial operational handover requirements.

Required Qualifications

Educational Qualification

Preferred qualifications include:

  • B.Pharm / M.Pharm
  • B.Sc / M.Sc in Life Sciences
  • Pharm.D
  • Bachelor’s or Master’s Degree in Clinical Research / Biotechnology / Biomedical Sciences

Experience Requirements

  • Minimum 3+ years of clinical monitoring / Clinical Research Associate experience
  • Prior experience in:
    • Site monitoring
    • Clinical trial execution
    • Regulatory documentation
    • Investigator/site coordination
  • Freshers are not eligible for this senior role