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

Global Channel Management Atlanta, United States

4 weeks ago

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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