Clinical Research Associate (Raritan, IL)

Clinical Research Associate

s www.globalchannelmanagement.com jobopeningsjobs(at)globalcahannelmanagement.c omClinical Research Associate needs 2 years of site management and field monitoring experience.Clinical Research Associate requires BS BA MS is desirable 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 Microsoft Office proficiency 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 Experience in Cardiovascular Therapeutic area IVD Study Experience Medidata RAVE system Clinical Research Associate duties Performs Interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete 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 weekly meetings