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