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