Clinical Research Associate

From 2 to 4 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

  • Conduct site feasibility (Identification & selection)
  • Perform EC submission
  • Prepare/Review of SIV package (including SMF).
  • Coordination with various stake holders eg. IP depo, IVRS, central laboratory, logistics, vendors etc for site related activities
  • Ensure that the sites have the required clinical supplies for proper conduct of the study.
  • Perform site visits i.e. site selection, initiation, monitoring & close out, prepare and submit follow up letter, visit reports as per SOP & monitoring plan
  • Perform SDV & CRF review as per the monitoring plan
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
  • Follow up with sites for issue resolution and implementing CAPA.
  • Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
  • Follow up with data management team for timely resolution of data queries.
  • Co-ordinate with sites in case of SAEs and ensuring timely reporting to all stakeholders
  • Initiate & track investigator, site and vendor payments.
  • Review & timely update Trial Master File & 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.
  • Author or review SOPs as and when designated.
  • Complete assigned trainings & maintain updated personal training file for records.

Role:Clinical Assistant

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Healthcare & Life Sciences

Role Category:Other Hospital Staff

Employment Type:Full Time, Permanent

Education

UG:B.Pharma in Any Specialization

PG:M.Pharma in Any Specialization

Company Profile

Alkem Laboratories Ltd

Alkem Laboratories Ltd

Company Info
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Contact Company:Alkem Laboratories Ltd

Address:ALKEM HOUSE,,DEVASHISH,SENAPATI BAPAT MARG,LOWER P, AREL MUMBAI, MUMBAI, Maharashtra, India