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    Senior Initiation Clinical Research Associate

    Parexel
    3-7 years
    Not Disclosed
    Bangalore
    10 May 22, 2024
    Job Description
    Job Type: Full Time Education: Any Graduate 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 Title: Senior Clinical Research Associate

    Company: Parexel

    Location: Near Boston, Massachusetts, and Durham, North Carolina

    Job Type: Full Time

    Function: Clinical Research

    Job Description:

    At Parexel, we share a common goal - to improve the world's health. From clinical trials to regulatory consulting and market access, our clinical development solutions are driven by a deep conviction in our mission. As a Senior Clinical Research Associate, you will contribute to the development of therapies that benefit patients, working with empathy, commitment, and a personal touch.

    Key Accountabilities:

    Start-up (from site identification through pre-initiation):

    • Serve as Parexel’s direct point of contact with assigned sites, ensuring quality and delivery during the start-up phase.
    • Build relationships with investigators and site staff.
    • Conduct feasibility and/or site pre-qualification and qualification activities.
    • Negotiate and execute Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs), and amendments.
    • Prepare for and conduct Qualification Visits (QVs).
    • Generate visit/contact reports and address site issues.
    • Develop strategies for regulatory document preparation, IRB/IEC and MoH/RA submission/approval, and patient recruitment & retention.

    Maintenance (from initiation through close out):

    • Assess overall study implementation and adherence to protocol at clinical sites.
    • Address and resolve site issues and provide ongoing support.
    • Conduct on-site visits and remote visits/contacts as needed.
    • Review and approve updated/amended site documentation.
    • Evaluate site recruitment plan and provide strategy for improvements.
    • Monitor and maintain compliance with regulations and guidelines.
    • Delegate administrative tasks and guide support team members.

    Overall Accountabilities from Site Identification to Closeout:

    • Ensure timely completion of project goals and update of trial management systems.
    • Work with team members to meet project goals and encourage support.
    • Maintain compliance with regulations, SOPs, and training requirements.
    • Provide input for Performance Development Conversations.
    • Act as a mentor and role model for team members.

    Skills:

    • Strong problem-solving skills
    • Initiative and ability to work independently
    • Excellent presentation and client-focused approach
    • Flexibility and ability to prioritize tasks
    • Strong computer and interpersonal skills
    • Attention to detail and sense of urgency
    • Ability to work in a team and across cultures

    Knowledge and Experience:

    • Substantial Site Management experience or equivalent in clinical research
    • Understanding of clinical trials methodology and terminology

    Education:

    • Degree in biological science, pharmacy, or related discipline preferred, or equivalent experience

    Note: Must hold a driver’s license where required.

    Parexel, headquartered near Boston, Massachusetts, and in Durham, North Carolina, employs over 16,000 people globally, supporting clients in over 100 countries. We offer comprehensive drug development capabilities, including global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services, to move you smoothly through the development journey.

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