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    Senior Clinical Research Associate

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 Oct. 30, 2024
    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

    About This Role

    Key Accountabilities:

    Start-up (From Site Identification Through Pre-Initiation):

    • Serve as Parexel’s primary contact for assigned sites, ensuring quality and timely delivery during the start-up phase.
    • Build and maintain relationships with investigators and site staff.
    • Conduct feasibility assessments and manage site pre-qualification and qualification activities, including:
      • Preparation and negotiation of Confidentiality Agreements (CDA), Clinical Site Agreements (CSA), and amendments.
      • Conducting remote Qualification Visits (QVs).
    • Generate visit/contact reports, identifying and resolving site issues proactively.
    • Develop strategies for country-specific and site-specific document management, including Informed Consent Forms (ICF) and regulatory submissions.
    • Prepare and submit applications to IRB/IEC and MoH/RA, ensuring all follow-ups are handled until final approvals are received.
    • Maintain accurate records in the trial master file and update Clinical Trial Management Systems (CTMS) promptly.

    Maintenance (From Initiation Through Close-Out):

    • Act as the primary contact for assigned sites, ensuring adherence to study protocols and resolving site issues.
    • Facilitate site access to relevant study systems and ensure compliance with training requirements.
    • Evaluate on-site staff assignments and implement corrective actions as needed.
    • Monitor and follow up on site issues, data quality, and compliance with training requirements.
    • Conduct on-site and remote visits, generating reports and evaluating site performance.

    Overall Accountabilities:

    • Ensure timely completion of project goals and maintain accurate updates in trial management systems.
    • Collaborate with team members to meet project objectives and provide strategies for efficient project planning.
    • Ensure all assigned sites are audit-ready and compliant with ICH-GCP and local regulations.
    • Delegate tasks to the Administrative Support Team, providing guidance and feedback on performance.
    • Foster a positive, results-oriented work environment and maintain high-quality work standards.

    Skills

    • Strong problem-solving abilities and initiative to work independently.
    • Excellent presentation and client-focused communication skills.
    • Ability to prioritize multiple tasks and make decisions in ambiguous situations.
    • Proficient in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office products.
    • Strong interpersonal skills with a commitment to high-quality work and team collaboration.
    • Willingness to travel as required and mentor team members.

    Knowledge and Experience

    • Substantial site management experience or equivalent experience in clinical research, with a strong understanding of clinical trial methodologies and terminology.

    Education

    • Educated to degree level in biological sciences, pharmacy, or a health-related discipline, or equivalent nursing qualification or relevant experience.

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