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    Sr. Clinical Research Associate

    Sun Pharma
    4-5 years
    Not Disclosed
    Gurgaon India
    10 Feb. 11, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Clinical Research Associate (Sr. CRA)
    Location: India Cluster
    Job Type: Full-time
    Travel Estimate: Frequent

    Job Summary:

    The Sr. CRA is responsible and accountable for the deliverables of clinical studies assigned to the RCO unit. This role involves end-to-end study-related onsite and remote monitoring, quality data review, and essential documents management for studies managed in-house. The Sr. CRA ensures that studies are completed within the agreed timelines, budget, and desired quality standards, in compliance with standard operating procedures, regulatory requirements, ICH GCP, and Sun Procedural Documents.

    Key Areas of Responsibility:

    Study Execution and Compliance:

    • Ensure clinical trials are conducted at assigned sites according to the protocol, local regulatory requirements, ICH GCP, and ethical standards (Declaration of Helsinki).
    • Act as the primary communication point between Sun Pharma (SPIL) and clinical trial sites regarding site management activities.
    • Facilitate regulatory submissions and ensure timely IRB/IEC approvals.
    • Ensure essential documents are prepared, submitted, and tracked as per site/IEC requirements.

    Site Management and Monitoring:

    • Conduct site selection visits and perform site feasibility assessments.
    • Ensure sites are updated with the latest feasibility results and actions from site selection visits (SSV).
    • Plan and conduct IRB submissions and ensure the submission of required documents for site/IEC approvals.
    • Review translated study documents to ensure accuracy and compliance.
    • Negotiate study budgets with sites and ensure timely execution of Clinical Trial Agreements (CTAs).
    • Process site invoices according to the executed CTA and track site-related payments.
    • Ensure site-related information is updated in essential systems (e.g., PI, site contact details, IEC).

    Site Visits and Training:

    • Conduct Site Initiation Visits (SIVs) and provide necessary training to the study team on study-related documents, processes, and amendments.
    • Perform onsite monitoring visits as per the Site Monitoring Plan and follow up on action items in a timely manner.
    • Provide periodic updates to the Regional Trial Leaders (RTL) and management on study progress, deliverables, risks, and quality.
    • Coordinate with cross-functional units (Quality, Data Management, Medical team) to ensure efficient study conduct.

    Study Supplies and Recruitment:

    • Ensure that Investigational Medicinal Product (IMP) supplies are available at sites, coordinating with RTLs and Trial Operations Managers for resupply orders.
    • Manage and track recruitment and retention strategies at sites and communicate recruitment risks proactively to RTLs.
    • Ensure site readiness for audits, inspections, and quality oversight visits.
    • Manage site supplies (ancillary supplies, e-diaries, recruitment materials, lab kits, etc.) throughout the study.

    Compliance and Documentation:

    • Ensure compliance with onsite visit requirements, safety reporting, and interim/final database lock (DBL) requirements.
    • Prepare sites for audits and inspections, ensuring all essential documents are filed in the Investigator File (ITF) and Trial Master File (TMF).
    • Conduct site closeout visits and follow-up as per the defined process.
    • Ensure visit reports and follow-up letters are submitted, approved, and filed in the TMF.

    Outsourced Trials:

    • Conduct accompanied visits with CRO monitors to ensure quality, Principal Investigator (PI) oversight, and site management.
    • Share observations and ensure actions and CAPAs from accompanied visits are followed until closure.

    Geographic Scope:

    • India Cluster

    Education and Qualifications:

    • Minimum Qualification: Pharmacy Graduate (4 years) or Postgraduate in Pharmacy or other science/healthcare fields.
    • Preferred Qualifications: Additional relevant qualifications will be a plus.

    Experience:

    • A minimum of 5 years of experience in clinical research.
    • At least 3-4 years of onsite monitoring experience for Phase II/III global clinical trials.

    Skills and Competencies:

    • In-depth knowledge of clinical research processes, ICH GCP, regulatory requirements, and the ethical conduct of clinical trials.
    • Strong site management and monitoring skills.
    • Excellent communication, negotiation, and interpersonal skills.
    • Ability to mentor and train junior staff and work effectively with cross-functional teams.
    • Strong attention to detail and commitment to data integrity and patient safety.

    Work Conditions:

    • Full-time position with frequent travel as required.

    Why Join Us:

    • Impact: Play a critical role in ensuring the successful execution of clinical trials.
    • Growth: Opportunity to mentor and lead a team while advancing your career in clinical research.
    • Innovation: Work with cutting-edge clinical trial management and monitoring technologies.

    If you are an experienced Senior CRA passionate about clinical research and making an impact, apply now to be a part of our dynamic team!

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