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    Clinical Research Associate - Remote

    Merck Group
    2+ years
    $91,600.00 - $144,100.00
    Remote, USA
    15 June 10, 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, 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

    Position: Clinical Research Associate

    Company: Merck & Co.

    Location: Rahway, New Jersey, United States

    Job Type: Full-time

    Category: Clinical Research

    Post Date: 06/05/2024

    Description:

    As a Clinical Research Associate (CRA) at Merck & Co., you will be accountable for performance and compliance for assigned protocols and sites in the country. Reporting to the CRA manager, you will ensure study conduct compliance with ICH/GCP and country regulations, policies, and procedures. The role involves acting as the primary site contact and manager throughout all phases of a clinical research study, with a focus on expanding the territory for clinical research and developing new sites. Additionally, you will participate in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems.

    Responsibilities:

    • Develop strong site relationships and ensure continuity through all trial phases.
    • Perform clinical study site management/monitoring activities in compliance with relevant guidelines, laws, and protocols.
    • Gain an in-depth understanding of the study protocol and related procedures.
    • Coordinate tasks with other sponsor roles to achieve Site Ready status.
    • Conduct remote and on-site monitoring activities to ensure data accuracy and subject safety.
    • Conduct site visits, including validation, initiation, monitoring, and close-out visits.
    • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
    • Communicate with Investigators and site staff on protocol-related issues and overall site performance.
    • Identify, assess, and resolve site performance or compliance problems and escalate as appropriate.
    • Collaborate with internal and external stakeholders to support assigned sites.
    • Manage and maintain information in various systems such as CTMS and eTMF.
    • Contribute to CRA team knowledge by acting as an SME and sharing best practices.
    • Support audit/inspection activities as needed.
    • Contribute to the identification of new potential sites and develop strong clinical research capabilities.

    Travel Requirements:

    • Ability to travel domestically and internationally approximately 65%-75% of working time.
    • Expected traveling approximately 2-3 days/week.
    • Current driver's license preferred.

    Qualifications, Skills & Experience:

    Core Competency Expectations:

    • Fluent in Local Languages and English (verbal and written) with excellent communication skills.
    • Good understanding of clinical research, GCP/ICH guidelines, and local clinical research laws.
    • Hands-on knowledge of Good Documentation Practices.
    • Proven skills in site management, including patient recruitment.
    • Proficient in MS Office and various clinical IT applications.
    • Ability to manage complex issues and work in a solution-oriented manner.
    • Effective time management, organizational, and interpersonal skills.
    • Ability to work independently and collaborate in a multicultural environment.
    • High sense of accountability and urgency.
    • Demonstrates commitment to customer focus, quality, and compliance.

    Experience Requirements:

    • Minimum 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

    Educational Requirements:

    • Preferred: B.A./B.S. with a strong emphasis in science and/or biology.

    Salary Range:

    • $91,600.00 - $144,100.00

    Benefits:

    • Bonus eligibility, long-term incentive if applicable, health care and other insurance benefits, retirement benefits, paid holidays, vacation, and sick days.

    Application Deadline: 06/12/2024

    Note: This job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please ensure you apply before the end date.

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