Lead – Clinical Research Associate

From 4 to 8 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

  • Lead clinical studies to ensure that study is conducted in compliance with the protocol, Sponsors SOPs, Good Clinical Practice (GCP) and relevant regulatory guidelines
  • Perform following monitoring activities directly or mange through SMO/ CRO
    • Perform/ Review/ Oversee Site Identification and conduct Feasibility Studies
    • Perform/ Review/ Oversee Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
    • Ensure Follow Up letters to sites are sent and submit Visit Reports to the Clinical Project Manager as required
    • Training of study team/ clinical sites on Protocol and other applicable regulatory guidelines including local regulatory guidelines
    • Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities along with internal stakeholders
    • Ensure timely Ethics Committee Submission by sites
    • Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
    • Verify drug accountability at sites and at Himalaya and supply/ resupply of study materials
    • Timely CRF retrieval as per the project instructions
  • Support the Clinical Project Manager in overall management of the assigned studies. Provide study status updates to team members and project management team and facilitate timely completion of projects
  • Updation of clinical study trackers (including study update/ finance tracking)
  • Maintain accurate and timely sponsor/ CRO/ SMO /site correspondence and communication
  • Primary point of contact for Internal stakeholders including Clinical Project Manager, PMD, DSG, F&D etc.
  • Ensure Central Site Files and Project Management Files are up to date and conduct period review as per SOP/ project requirements
  • Coordination for Archival of study documents (Both in soft copies and hard copies).

Role Requirements:

  • Degree (Graduation or Post Graduation) in science or pharmacy (BSc/BDS/ B.Pharm/ M. Pharm/ M.Sc) with 4-5 years of experience with clinical study monitoring at sponsor or CRO company is preferred.
  • A satisfactory previous experience of monitoring & clinical trial activities
  • Must have thorough knowledge of clinical trial concepts including ICH GCP and relevant regulations for the conduct of clinical trials
  • Fluent in written and spoken English & proficient in MS Office.
  • It may be required for the employee to travel up-to approx. 25- 50%.

Key Skills
Skills highlighted with ‘‘ are preferred keyskills


PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization

Company Profile

The Himalaya Drug Company

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
Company Info
View Contact Details+

Contact Company:The Himalaya Drug Company



Not Disclosed by Recruiter

Functional Area:

Research & Development

Role Category:

Pharmaceutical & Biotechnology


Clinical research Scientist

Employment Type:

Full Time, Permanent