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    Clinical Research Associate

    Dr Reddy's
    3-7 years
    Not Disclosed
    Hyderabad
    10 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description: Clinical Research Liaison (CRL)

    Responsibilities

    1. Site Management and Integrity:

      • Act as DRL’s direct contact with assigned sites.
      • Assess and ensure overall integrity of the study.
      • Implement and adhere to the study protocol at clinical investigational sites.
      • Resolve site issues and escalate unresolved issues to COL/PL.

    2. Relationship Building:

      • Build and maintain relationships with investigators and site staff.
      • Facilitate and support site access to relevant study systems.
      • Ensure sites are compliant with project-specific training requirements.

    3. Oversight and Compliance:

      • Ensure adequate oversight of clinical trials by the Investigator.
      • Address and resolve site issues, including additional training needs and documentation deficiencies.
      • Address, evaluate, resolve, and escalate issues from previous visits.
      • Evaluate site recruitment plans and collaborate with site staff for improvements.

    4. Data Quality and Integrity:

      • Identify and evaluate potential data quality and data integrity issues.
      • Implement appropriate follow-up actions.

    5. Meetings and Inspections:

      • Participate in Investigator and other external or internal meetings.
      • Participate in audits and regulatory inspections as required.

    6. Documentation and Compliance:

      • Collect, review, and approve (if applicable) updated/amended site documentation.
      • Ensure IRB/IEC periodic updates are in place as applicable.
      • Perform on-site visits, including Qualification and Initiation visits.
      • Conduct remote visits/contacts as needed and generate visit reports.

    7. Performance Evaluation:

      • Evaluate overall compliance and performance of sites and site staff.
      • Provide recommendations regarding site-specific actions.
      • Assess the ability and motivation of site staff.

    8. Follow-Up and Reporting:

      • Follow up on CRF data entry, query status, and SAEs.
      • Review and follow up on site payment status.
      • Recognize and communicate the impact of study non-compliance, issues, delays, or changes on study timelines.
      • Propose strategies for resolution.

    9. Quality Control:

      • Review and QC of TMF (Site/Country part).
      • Review ISF during on-site monitoring visits (MVs).
      • Review CIFs in-house.

    Requirements

    • Education and Experience:

      • [Specify required education and experience here]

    • Skills and Competencies:

      • Strong interpersonal and communication skills.
      • Ability to manage and resolve site issues independently.
      • Proficiency in relevant study systems and compliance requirements.
      • Strong judgment and decision-making abilities regarding data quality and integrity.
      • Ability to manage site recruitment plans and improve strategies.
      • Familiarity with regulatory documentation and compliance.

    This structured format provides a clear and concise breakdown of the responsibilities, requirements, and expectations for the role of a Clinical Research Liaison.

     

     

     

     

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