Remote Women's Fertility Clinical Research Associate III

Remote Women's Fertility Clinical Research Associate IIIAbout the job Remote Women's Fertility Clinical Research Associate IIIRemote Clinical Research Associate III needs 2 years of site management and field monitoring experienceRemote Clinical Research Associate III requires:Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pmESTQualifications:BS/BAMinimum of 2 years of site management and field monitoring experienceKnowledge of applicable standards and regulations for clinical trialsProven oral and written communication skillsProven planning skills; ability to create and track detailed project plansProven interpersonal, leadership, organizational and effective time management skillsDemonstrated experience in computer skills to include Microsoft Word, Excel and basic templatesAbility to work independently and within a cross-functional team environment to identify and elevate site/monitoring related activities issues to the management team in a timely fashionPreferred:Experience in womens fertilityVD Study ExperienceMedidata RAVE systemRemote Clinical Research Associate III duties:Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and completeManages site communication and escalates to leadership in a timely fashion when neededApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelinesRoutinely 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 reportsSite support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetingsJ-18808-Ljbffr