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.firstname.lastname@example.org”
- 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.