Senior Clinical Research Associate

Senior Clinical Research Associate

Experience, Skills, Knowledge, and Education Requirements:

  • 5 to 7 years of experience in clinical operations
  • Should have experience in Phase I, II, III drug trials
  • Earlier experience in line management activities
  • Good communication skills both oral and written are a must
  • Applies strong analytical and business communication skills
  • Familiarity with medical terminology and/or GCP guidelines strongly preferred
  • Applies technical standards, principles, theories, concepts, and techniques
  • Excellent organizational skills are required
  • Demonstrated success in problem solving
  • Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job
  • Detail oriented
  • Ability to work in a team environment
  • Self-motivation, eagerness to grow professionally and commitment to self-development
  • Occasional travel may be required.
  • Education: Any life science degree. Preferably pharmacy (B. Pharmacy/M. Pharmacy/ PharmD)


    Job Responsibilities:

  • Project Management
  • Manage studies independently under directions of Clinical Director
  • Prepare study execution strategies, challenges, and mitigations
  • Forecast study expenses and support Management
  • Prepare project management plans, Gantt charts, study plans
  • Preparing and conducting pre- study activities, site selection, initiation visits, routine monitoring and close- out visits and performing feasibilities.
  • Preparing applications to ethics committees and supporting the regulatory department with the application to the regulatory authorities.
  • Planning and participating at Investigator meeting(s) responsible for the site(s) and on- site management during the study process.
  • Ordering and coordinating study supplies.
  • Preparing study documentation and assisting the Clinical Quality Assurance Manager/ regulatory authorities during audits/ inspections in- house or on site.
  • Negotiating contracts with the clinics, local/ central laboratory (ies)/ pharmacy etc.
  • Responsibility for the final archiving of all study documentation in- house Monitoring and Oversight communicating with study teams and sponsors.
  • Regulatory Documentation Management Administration Providing Status Reports to line manager.
  • Planning budget activities for the trials Managing timelines and deliverables for the trials.
Job Type: Full Time
Job Location: Bengaluru

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