Opportunity for M.Pharm as Clinical Research Associate at Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post : Clinical Research Associate
• 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.
Qualification : M.Pharm
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Skills Required : CRA
End Date : 15th April, 2020.