Pharma Job : Clinical Research Associate Post @ Sun Pharma

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Research Associate Positions @ Centre of Biomedical Research (CBMR)

Pharma Job : Clinical Research Associate Post @ Sun Pharma

Sun Pharmaceutical Industries Ltd is hiring for pharma candidates. Sun Pharmaceutical Industries Ltd  pharma jobs for eligible candidates.  Clinical Research Associate post for pharma candidates is available as per the details on the same below:

Job Title:  Clinical Research Associate

Experience: 4 – 7 Years

Location: Mumbai

Job Description:

  • Conduct site feasibility and assist PM in site identification & selection.
  • Coordinate with investigator and sites for IM and assist PM in planning for IM, if applicable.
  • Perform EC submission related activities including co-ordination with site team & other stakeholders.
  • Prepare/Review of SIV package (including SMF).
  • Co-ordination & tracking for dispatch, maintenance & retention/disposition of Clinical trial supplies (IP & non-IP) as per SOP & study requirement.
  • Ensure that the sites have the required clinical supplies for proper conduct of the study.
  • Prepare & finalize study specific documents (manuals, plans, logs etc.).
  • Perform site visits (eg. SQV, SIV, SMV, SCV etc), prepare and submit follow up letter, visit reports as per SOP & study requirements.
  • Resolve site & vendor related open action items.
  • Follow up with data management team and investigator/site team for timely resolution of issues/data queries.
  • Co-ordinate SAE reporting related activities with internal & external stakeholders.
  • Initiate & track investigator, site and vendor payments.
  • Review & timely update Trial Master File (TMF/eTMF) & study folder as per SOP/study requirements.
  • Maintain and update study trackers (eg. Annexure I) & systems (e.g. CTMS) for the assigned projects.
  • Regularly obtain updated trackers/logs from sites, as applicable.
  • Follow up with the sites/vendors for all the pending documents.
  • Keep the study project manager and other team members informed of updates from sites.
  • Co-ordinate study document archival at sites.
  • Train other team members, author or review SOPs as and when designated.
  • Complete assigned trainings & maintain updated personal training file for records.

Qualifications:

Education:

  • UG -B.Pharma – Pharmacy
  • PG – M.Pharma – Pharmacy

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