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

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    About the job Remote Women's Fertility Clinical Research Associate III

    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 womens 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