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    Senior Clinical Research Associate

    Parexel
    3+ years
    Preferred by Comapny
    India
    11 Nov. 25, 2024
    Job Description
    Job Type: Remote 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: Clinical Research Associate (CRA)

    Company: Parexel

    Role Overview

    As a Clinical Research Associate (CRA) at Parexel, you will serve as a key contact for investigator sites, ensuring the successful initiation, execution, and completion of clinical trials. You will contribute to the timely delivery of high-quality data while safeguarding the safety and well-being of trial participants. This role requires a dynamic professional with a proactive attitude, excellent problem-solving skills, and the ability to collaborate in a global, matrixed environment.

    Key Accountabilities

    Start-Up Phase (Site Identification to Pre-Initiation):

    • Act as Parexel’s primary point of contact with assigned sites, ensuring quality and delivery during start-up.
    • Conduct site feasibility, qualification, and pre-qualification activities, including remote Qualification Visits (QVs).
    • Negotiate, prepare, and facilitate the execution of Confidentiality Agreements (CDAs) and Clinical Site Agreements (CSAs).
    • Customize, review, and approve Informed Consent Forms (ICFs) and regulatory documents in compliance with country and client requirements.
    • Manage IRB/IEC and MoH/RA submissions, resolving conflicts and ensuring timely approvals.
    • Develop strategies for site activation, patient recruitment, and document compliance.
    • Maintain and update Clinical Trial Management Systems (CTMS).

    Maintenance Phase (From Initiation to Close-Out):

    • Act as Parexel’s direct contact with sites, ensuring adherence to study protocols and addressing site issues.
    • Facilitate site access to study systems, ensuring compliance with training requirements.
    • Monitor site recruitment plans and implement improvements as necessary.
    • Perform on-site and remote monitoring visits, addressing data quality and integrity issues.
    • Review site documentation, evaluate compliance, and resolve any non-conformance issues.
    • Conduct site-specific training and assessments to ensure smooth trial execution.
    • Collaborate on corrective and preventive action plans to mitigate risks.

    Overall Responsibilities:

    • Ensure timely and accurate completion of project goals.
    • Maintain a working knowledge of ICH-GCP guidelines, international/local regulations, and Parexel SOPs.
    • Ensure that assigned sites are audit and inspection ready.
    • Delegate and oversee administrative tasks as appropriate, providing mentorship and feedback.
    • Collaborate with cross-functional teams to drive project success.
    • Proactively communicate progress and challenges to management.

    Skills and Competencies

    • Strong problem-solving and analytical skills with the ability to make independent decisions.
    • Excellent interpersonal, verbal, and written communication skills.
    • Proficiency in Clinical Trial Management Systems (CTMS), EDMS, and MS Office.
    • Ability to manage multiple tasks and prioritize effectively.
    • Proven ability to work in a matrix and virtual team environment.
    • Client-focused approach with strong consulting and mentoring skills.
    • Flexibility to travel and meet project-specific requirements.

    Knowledge and Experience

    • Substantial experience in site management or clinical research with a solid understanding of clinical trial methodology and terminology.
    • Familiarity with regulatory submission processes and quality standards.
    • Experience with cross-cultural collaborations in a global work environment.

    Education

    • Degree in biological sciences, pharmacy, nursing, or a related health discipline.
    • Equivalent experience in clinical research or site management may be considered.

    Join Parexel to make a meaningful difference in advancing healthcare. Collaborate with global teams, grow your expertise, and be a part of a results-driven organization committed to innovation, quality, and patient safety.

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