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.