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    Remote Women's Fertility Clinical Research Associate III - Atlanta, United States - Global Channel Management

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    Description

    Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience

    Remote Clinical Research Associate III requires:

    • Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm

    • EST

    Qualifications:

    • BS/BA

    • Minimum of 2 years of site management and field monitoring experience

    • Knowledge of applicable standards and regulations for clinical trials

    • Proven oral and written communication skills

    • Proven planning skills; ability to create and track detailed project plans

    • Proven interpersonal, leadership, organizational and effective time management skills

    • Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates

    • Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion

    Preferred:

    • Experience in women's fertility
    • VD Study Experience
    • Medidata RAVE system
    Remote Clinical Research Associate III duties:

    • Performs Site initiation, interim & close out monitoring visits

    • Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete

    • Manages site communication and escalates to leadership in a timely fashion when needed

    • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

    • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

    • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

    • Documents activities via confirmation letters, follow-up letters, trip reports

    • Site support throughout the study lifecycle from site identification through close-out
    • Attends and participates in internal meetings

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