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