Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Research Associate

Dr.Reddy's
Dr.Reddy's
3-7 years
Not Disclosed
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.