Sun Pharma Hiring: Clinical Research Associate (CRA) in Gurgaon - Apply Now!
Location: Gurgaon - R&D
Company: Sun Pharmaceutical Industries Ltd
Experience: Minimum 3 years in clinical research, 2 years in onsite monitoring for Phase II/III global clinical trials
Education: Pharmacy Graduate (4 years) or Post Graduate in Pharmacy or other science/healthcare fields
Sun Pharmaceutical Industries Ltd, a leader in the pharmaceutical industry, is seeking a highly skilled and motivated Clinical Research Associate (CRA) to join our R&D team in Gurgaon. This role is crucial for ensuring the successful conduct of clinical trials, maintaining quality data review, and adhering to regulatory requirements.
Job Summary of Sun pharma CRA
CRA is responsible and accountable for deliverables of studies assigned to RCO unit, performing end to end study related onsite/ remote monitoring, quality data review, essential documents management for studies managed in-house with-in agreed timelines, budget and desired quality standards. CRA is expected to adhere to required standard operating procedures, regulatory requirements, ICH GCP and quality in compliance with Sun Procedural Documents.
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Sun Pharma Hiring: Clinical Research Associate (CRA) in Gurgaon - Apply Now![/caption]
Area Of Responsibility
- Ensures clinical trials are conducted at assigned sites as per protocol, local regulatory requirements, ICH GCP, ensure data integrity, patient safety and trials are conducted as per ethical standards (declaration of Helsinki).
- Act as primary communication point between SPIL and clinical trial site w.r.t site management activities.
- Facilitating regulatory submission
- Perform site feasibilities, ensure site database is updated on periodic basis with feasibility results
- Identify, plan and conduct Site Selection visits, ensure actions from SSV’s are followed up with the assigned team.
- Planning and performing IRB submissions in an efficient manner to secure timely approvals, ensure IRB/IEC dossiers are prepared and submitted as per site/IEC requirements.
- Review of the Translated documents of the study
- Negotiating study budgets with sites, ensure Clinical Trial Agreements are executed in timely manner
- Ensure timely processing of the site invoices per the executed CTA and tracking all the site related payments during the conduct of the studies assigned.
- Ensure the site related details are correctly & timely updated in the essential systems for assigned studies. (For e.g., Contact details of site/ PI/ HOI/ IEC)
- Responsible to perform SIV and training to the study team. Ensure the sites are regularly trained on the study related documents, amendments, processes during conduct of the study.
- Ensure planning and conducting of Onsite Monitoring Visits as per Site Monitoring Plan and follow up on the open action items in a timely manner.
- Provide periodic updates to RTLs and management on study progress, deliverables, risks and quality.
- Collaborate and lead communication with cross-functional units (Quality, DM, Medical team, and other stakeholders to ensure efficient conduct the study.
- Ensure IMP supplies are adequate at sites and coordinate promptly with RTLs & Trial Operation Manager(s) for initial and resupply orders, manage IP supply scheme at site as per recruitment progress, ensure IMP supplies are received & stored per the protocol requirements.
- Manage and ensure all the study protocol required supplies are adequate at the site(s) during conduct of the study (For e.g., Ancillary supplies, e-diaries, recruitment and patient facing & retention materials, Lab kits, etc.
- Plan and track recruitment / retention strategies at site, ensure study recruitment risks are communicated pro-actively to RTLs and
- propose alternative solutions and actions are communicated and followed up to the investigator(s) in a timely manner.
- Ensure compliance with Onsite visits, action items, PD & SAE reporting requirements along with meeting the interim and final DBL requirements of the assigned studies.
- Ensure sites readiness for audits, inspections and actively involved in preparation and managing Sites for Audits, Inspection and quality/ oversight visits.
- Review and ensure all the essential documents are filed in ITF and TMF
- Perform sites closeout visits and follow up as per defined process
- Coordinate with PI/site team to ensure sites have adequate time and fulfil their obligations to the study conduct.
- Ensure the Visit reports/FU letters are timely submitted & approved and are sent/filed in TMF
- Communicate/escalate compliance issues, trends noted to RTLs.
- Ensure healthy relations & effective communication maintained with the site team.
- Play an active role in planning, managing Investigator meetings
How to Apply
Interested candidates should submit their
resume and a cover letter detailing their qualifications and experience. Apply online at
Sun Pharma Careers.
https://pharmastuff.org.in/job/sun-pharma-hiring-clinical-research-associate-gurgaon
