Dr Reddy’s Hiring Clinical Research Associate

Dr Reddy’s Hiring Clinical Research Associate

15 April, 2022

Dr Reddy’s Hiring for 06 Clinical Research Associates across India.

Preferably from Metro cities having access to Air travel and can work remote.

4-8 yrs of relevant experience can apply from the below link or mail across ”Nareshkumar.g@drreddys.com

Job Description

  • Responsible for specific study sites and includes the following:
  • Responsible to coordinate the implementation of clinical protocol and documentation at the assigned sites in accordance with GCP, company/sponsor SOPs (as applicable), and Applicable regulatory requirements.
  • Assist in the conduct of feasibility studies.
  • Assist in the preparation and finalization of Confidentiality Agreements and Clinical Trial Agreements.
  • Coordinate start-up activities and ensure timely IRB/ IEC submissions (initial and subsequent approval, annual status reports, etc).
  • Prepare Investigator Site File (ISF) as well as in-house study files, compile and review the regulatory documents of the sites as per the filing structure approved for the study
  • Coordinate with the assigned sites to procure documents required for regulatory submission (e.g. CV and undertaking of the Investigator, IRB/ IEC approval, etc.) and review them.
  • Coordinate with assigned sites and assist in conducting the Investigator meeting.
  • Coordinate, schedule, and conduct site initiation, routine monitoring, and closeout visits as per protocol and monitoring plan.
  • Verify whether the most updated IRB/ IEC approved informed consent forms are used by the site during the consent process and the informed consent process is appropriately documented for each study patient
  • Review source documents and verify against the electronic case report forms (e-CRFs) for completeness, accuracy, and compliance.
  • Generate manual data correction forms; assist the site in the resolution of these queries as well as Data Management queries
  • Ensure that non-serious and serious adverse events are documented and reported in
  • Compliance with safety reporting procedures/timelines.
  • Reconcile regulatory documents filed in the ISF with in-house study files during the monitoring visits to ensure availability and accuracy.
  • Escalate the non-compliances identified at the site to the applicable stakeholders within the defined timelines and implement the recommended corrective and preventive action in consultation with the Project Manager/ Operations lead.
  • At the end of the visit, prepare and finalize the site visit report as per the defined timelines.
  • Coordinate and follow-up with all stakeholders involved in the study for resolution of site-specific issues.
  • Prepare and update the project tracking tools and study reports
  • Prepare assigned study sites for internal, Sponsor audits, and/or Regulatory inspections and resolve the QA findings at the assigned sites, within the given timeline.

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