Remote Women's Fertility Clinical Research Associate III

Global Channel Management

  • Atlanta, Georgia
  • 30+ days ago
  • Remote

    Highlights

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

    Numbers & Facts

    LocationAtlanta, Georgia (
    Remote
    )

    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 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

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