Clinical Research Associate III, Women's Fertility

2 days ago

Apply Now

Receive Emails with Similar Jobs

Global Channel Management, Inc.

WebsiteLinkedInAll Job Openings

Employment • Software • Placements • Hardware • Technoloy

11 - 50

Description

• 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

Requirements

• 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