Sun Pharma Clinical Research Associate Jobs, Apply Online
Title: Sr. Clinical Research Associate
Date: Jan 30, 2025
Location: Gurgaon – R&D
Company: Sun Pharmaceutical Industries Ltd
Job Summary
Sr. CRA is responsible and accountable for deliverables of studies assigned to the RCO unit, performing end-to-end study-related onsite/remote monitoring, quality data review, and essential document management for studies managed in-house within agreed timelines, budget, and desired quality standards.
Sr. CRA is expected to adhere to required standard operating procedures, regulatory requirements, ICH GCP, and quality compliance with Sun Procedural Documents.
Area Of Responsibility
- Ensures clinical trials are conducted at assigned sites as per protocol, local regulatory requirements, and ICH GCP, ensuring data integrity, patient safety, and adherence to ethical standards (Declaration of Helsinki).
- Acts as the primary communication point between SPIL and clinical trial sites for site management activities.
- Facilitates regulatory submission.
- Trains and mentors CRAs as applicable.
- Supports RTLs on trial management tasks as delegated.
- Performs accompanied site visits with CRAs where required.
- Participates in Quality Oversight activities as assigned by RTLs.
- Conducts site feasibilities and ensures site database updates with feasibility results.
- Identifies, plans, and conducts Site Selection Visits (SSVs) and ensures follow-up actions.
- Plans and performs IRB submissions efficiently to secure timely approvals and ensures IRB/IEC dossiers are prepared and submitted per site/IEC requirements.
- Reviews translated study documents.
- Negotiates study budgets with sites and ensures Clinical Trial Agreements (CTAs) are executed on time.
- Ensures timely processing of site invoices per executed CTA and tracks all site-related payments.
- Updates site-related details accurately and promptly in essential systems.
- Performs Site Initiation Visits (SIV) and trains study teams, ensuring regular training on study documents, amendments, and processes.
- Plans and conducts onsite monitoring visits as per the Site Monitoring Plan and ensures timely follow-up on open action items.
- Provides periodic updates to RTLs and management on study progress, deliverables, risks, and quality.
- Collaborates and communicates with cross-functional units (Quality, DM, Medical Team, and other stakeholders) for efficient study conduct.
- Ensures adequate IMP supplies at sites, coordinates with RTLs & Trial Operation Managers for initial and resupply orders, and manages IP supply per recruitment progress.
- Ensures all study protocol-required supplies are available at sites, including ancillary supplies, e-diaries, recruitment materials, lab kits, etc.
- Tracks recruitment/retention strategies at sites and communicates study recruitment risks to RTLs, proposing alternative solutions.
- Ensures compliance with onsite visits, action items, PD & SAE reporting requirements, and DBL requirements.
- Prepares sites for audits, inspections, and quality oversight visits.
- Reviews and ensures all essential documents are filed in ITF and TMF.
- Performs site closeout visits and follow-ups as per defined processes.
- Coordinates with PIs and site teams to ensure sites fulfill their obligations.
- Ensures timely submission and approval of visit reports and follow-up letters.
- Communicates and escalates compliance issues to RTLs.
- Maintains healthy relations and effective communication with site teams.
- Plays an active role in planning and managing Investigator Meetings.
For Out-sourced Trials:
- Conducts accompanied visits with CRO monitors to ensure quality, PI oversight, and site management.
- Shares observations with CRO-CRA post-visit.
- Ensures actions and CAPAs are followed until closure.
Geographic Scope/Market: India Cluster
Budget (if applicable): NA
Work Conditions: Full-time
Physical Requirements: Presence at work
Travel Estimate: Frequent
Education and Job Qualification: Minimum Pharmacy Graduate (4 Years) or Postgraduate in Pharmacy and other science/healthcare fields. Additional qualifications are preferred.
Experience: Sr. CRA should have at least 5 years of experience in clinical research and at least 3-4 years of onsite monitoring experience for Phase II/III global clinical trials.
Keywords: Sun Pharma, Clinical Research Associate, Sr. CRA, Gurgaon, R&D, Pharmaceutical, Healthcare Solutions, Clinical Trials, Regulatory Requirements. Sun Pharma Clinical Research Associate Jobs, Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
