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    Remote Women's Fertility Clinical Research Associate Iii

    Global Channel Management, Inc
    2+ years
    $49 to $50 per hour
    Remote
    10 Sept. 18, 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, 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

    Remote Clinical Research Associate III

    Requirements:

    • Work Schedule: Monday to Friday, either 7:00 AM - 3:30 PM or 8:00 AM - 4:30 PM EST.

    Qualifications:

    • Bachelor’s degree (BS/BA).
    • Minimum of 2 years of site management and field monitoring experience.
    • Knowledge of applicable standards and regulations for clinical trials.
    • Excellent oral and written communication skills.
    • Strong planning skills with the ability to create and track detailed project plans.
    • Proven interpersonal, leadership, organizational, and effective time management skills.
    • Proficiency in Microsoft Word, Excel, and basic templates.
    • Ability to work independently and within a cross-functional team, effectively identifying and escalating site/monitoring-related issues to management in a timely manner.

    Preferred:

    • Experience in women's fertility studies.
    • Experience with VD studies.
    • Familiarity with the Medidata RAVE system.

    Duties:

    • Conduct site initiation, interim, and close-out monitoring visits.
    • Verify that required clinical data entered in the electronic case report form (eCRF) is accurate and complete.
    • Manage site communication and escalate issues to leadership as needed.
    • Apply query resolution techniques both remotely and on-site, providing guidance to site staff and driving queries to resolution within agreed timelines.
    • Regularly review the Investigator Site File (ISF) for accuracy, timeliness, and completeness, and reconcile its contents with the Trial Master File (TMF).
    • Ensure that the investigator/physician site is aware of the requirements for archiving essential documents according to local guidelines and regulations.
    • Document activities through confirmation letters, follow-up letters, and trip reports.
    • Provide site support throughout the study lifecycle, from site identification through close-out.
    • Attend and participate in internal meetings.

    We look forward to your application!

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