Clinical Trial Associate

3 weeks ago


Hyderabad, India Dr Reddy's Laboratories Limited Full time
Job Description

Job Summary
The Clinical Trial Associate (CTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, filing and quality reviews as well as participating to process improvement initiatives across the departments.

 
Roles & Responsibilities

  1. Provide general administrative support to the Clinical Operations Department and assistance to the study team(s).
  2. Assist in the production of presentations as needed for project, departmental, and/or business development.
  3. Assists the team with Sponsor oversight, study specific documentation review and QC including review of ICF, study plans, study reference manuals, e-CRF, etc.
  4. Assist with creation and maintenance of study metrics trackers, tools and reports.
  5. Assist in co-ordination and tracking of Investigator and third-party payments.
  6. Ensures required study documents are submitted to the eTMF.
  7. Assists the team with Sponsor oversight of eTMFs periodic audit and findings resolution.
  8. Assist the team in executing clinical monitoring oversight.
  9. Assists with customisation of CDA, clinical site contracts & budgets, when applicable.
  10. Assist the clinical team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
  11. Co-ordinate document translation, if required.
  12. May participate in training CRO teams and in the on-boarding of new CRO team members.
  13. May contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc. when requested).
  14. Attends internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed.
  15. Other duties may be assigned as required.
  16. If required, the candidate should be willing to travel as needed (


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