Dr. Reddys Laboratories Ltd Recruitment 2021.Dr. Reddys Laboratories Ltd Notification full detailes below.Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.
Important Vacancy details:Dr. Reddys Laboratories Ltd hiring M.pharm for Clinical Research Associate At Hyderabad.Intrested Candidates apply Now.
- Post Name: Clinical Research Associate
- Qualification:M Pharm
- Location:Hyderabad, Telangana, India
Job Description: Hiring For Clinical Research Associate in Dr. Reddys Laboratories Ltd!
Responsible for specific study sites which 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.
- Co-ordinate 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 document 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.
- Assist the head of clinical operations in identifying & creating a database of investigators & study sites for different therapeutic areas.
Administrative responsibilities include:
- Travel as required and adhere to internal travel & expense reimbursement policies
- Participate in and contribute to personnel training seminars
- Maintain current knowledge of company standard operating procedure (SOP) and participate in the annual review of all SOPs.
- Ensure completion of training and update the Employee training file in a timely manner.
Selection Process: The selection will be on the basis of Interview.