Himalaya Drug Company Hiring Pharma Candidates - Clinical Research Associate

Himalaya drug company Hiring Pharma Candidates – Apply Online

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Job Title: Lead – Clinical Research Associate

Experience: From 3 to 7 years of experience

Location: Bangalore/Bengalur

Desired Candidate Profile

  • Degree (Graduation or Post Graduation) in science or pharmacy (BSc/BDS/ B.Pharm/ M. Pharm/ M.Sc) with 2-3 years of experience with clinical study monitoring at the sponsor or CRO company is preferred. Working as study site coordinator” at the reputed institute (in clinical operation) may also apply
  • A satisfactory previous experience of monitoring & clinical trial activities
  • Must have a 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%.

Clinical Research Associate:

Overview of the role

  • Monitoring of clinical study 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 Site Identification and conduct Feasibility Studies
  • Perform Site Selection Visit, Site Initiation Visits, Site Monitoring Visit and Site Closeout Visit
  • Send Follow Up letters to sites and submit Visit Reports to the Clinical Team Leader/ Project Manager as required
  • Training of Investigators/ 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
  • Coordinate for Ethics Committee Submission by sites
  • Ensure subject safety and adverse event reporting to sponsor and IRB/IEC
  • Verify drug accountability logs and storage requirements
  • CRF retrieval as per the project instructions
  • Support the Clinical Project Manager in the overall management of the assigned studies. Provide study status updates to team members and project management and facilitate project timelines
  • Updation of clinical study trackers (including study update/ finance)
  • Maintain accurate and timely sponsor/ CRO/ SMO /site correspondence and communication
  • Primary point of contact for Clinical Operations aspects of designated study sites/ CRO/ SMO
  • May be required to help in the preparation of Regulatory Binder (Preparation and submission of clinical documents for International Regulatory Dossiers as per the country standard formats)
  • Maintain updated Site Files and collection of the essential documents and project-related documents and maintain Central Study File
  • Coordinate and distribute Clinical Study Material to study sites.
  • Coordination of Archival of study documents

Apply Online

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