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Clinical Research Associate Post Vacant @ Sun Pharma

Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world.

Job Title : Clinical Research Associate

Experience : 1 – 5 Years

Location : Mumbai

Job Description:

  • Facilitate and coordinate with investigator and site for EC submission and approval.
  • Conduct site feasibility and qualification visits.
  • Get trained on trial and documents.
  • Prepare for kickoff
  • meetings to train vendor representatives involved if outsourced
  • activity for monitoring.
  • Coordinate with investigator and sites for IM and assist PM in planning for IM
  • Conduct SIVs, write SIV reports, and dispatch to sites
  • Resolve queries and problems at sites and with vendors.
  • Monitor sites, write monitoring visit reports and send timely monitoring followup
  • letters to sites.
  • Obtain updated weekly trackers from sites
  • Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
  • Coordinate with data management team and investigator/site team for timely DCF resolution.
  • Ensure CSR submission by investigator to EC, to regulatory authority (as applicable)
  • Conduct site closeouts
  • and write closeout
  • reports and dispatch to sites.
  • Arrange trial document archival at sites, inhouse,
  • and/or by third party as applicable.
  • Onsite Monitoring: more than 30

Desired Profile:

  • UG -B.Pharma – Pharmacy

Apply Online Here

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