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    Senior Clinical Research Associate

    Parexel
    1-3 years
    Not Disclosed
    Remote
    10 July 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description: Clinical Research Associate

    Company Overview: At Parexel, we share a unified goal—to improve the world's health. From clinical trials to regulatory, consulting, and market access, every solution we provide is underpinned by a deep conviction in our mission. Every team member contributes to developing therapies that benefit patients. Our work is personal, empathetic, and committed to making a difference.

    Position: Clinical Research Associate Location: Northeast Experience: 1-3 Years

    Roles and Responsibilities:

    Start-up Phase:

    • Serve as Parexel’s primary contact with clinical sites, managing site quality and delivery from site identification through pre-initiation.
    • Develop and maintain relationships with investigators and site staff.
    • Conduct and manage feasibility, site pre-qualification, and qualification activities.
    • Prepare, negotiate, and facilitate execution of Confidentiality Agreements (CDA) and Clinical Site Agreements (CSA).
    • Perform remote Qualification Visits (QVs) and generate visit/contact reports.
    • Develop and approve high-quality country-specific and/or site-specific documents.
    • Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and ensuring receipt of final approvals.
    • Update Clinical Trial Management Systems (CTMS) and maintain site documentation.
    • Forecast, develop, and manage plans for IRB/IEC submission, site activation, and patient recruitment.
    • Address site issues and escalate as necessary, including activation timelines and recruitment strategies.

    Maintenance Phase:

    • Act as the direct contact with assigned sites, ensuring study implementation and protocol adherence.
    • Facilitate site access to study systems and ensure compliance with training requirements.
    • Evaluate and resolve issues related to site staff, documentation, and communication.
    • Monitor data quality and integrity, addressing any potential issues.
    • Conduct on-site visits, including Qualification and Initiation visits.
    • Review and follow-up on site payment status, CRF data entry, query status, and SAEs.
    • Perform site-specific training and facilities assessments as needed.
    • Ensure compliance with ICH-GCP and local regulations.

    Overall Accountabilities:

    • Ensure timely and accurate completion of project goals and update applicable trial management systems.
    • Collaborate with team members to meet project goals and provide efficient project planning.
    • Maintain a positive, results-oriented work environment and build collaborative relationships.
    • Ensure compliance with ICH-GCP guidelines, Parexel SOPs, and study-specific procedures.
    • Develop expertise and become a subject matter expert.
    • Complete additional tasks in a timely manner, including timesheets and expenses.

    Skills:

    • Strong problem-solving and analytical skills.
    • Ability to work independently and seek guidance when necessary.
    • Excellent presentation and communication skills.
    • Client-focused approach with the ability to prioritize multiple tasks and meet deadlines.
    • Strong computer skills, including knowledge of CTMS, EDMS, and MS Office.
    • Ability to work across cultures and in a virtual team environment.
    • Proven ability to mentor and support team members.

    Knowledge and Experience:

    • Substantial site management or clinical research experience.
    • Understanding of clinical trials methodology and terminology.

    Education:

    • Degree in biological science, pharmacy, or other health-related disciplines preferred, or equivalent nursing qualification or experience.

    EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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