The Clinical Research Associate (CRA) - will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Therapeutic area is vascular (PVD, CAD, EP) and devices are stents, balloons, guidewires, AI, Peripheral vascular.
Provide leadership in execution of clinical studies to deliver high quality data to support sponsor on time, within budget and in compliance to all applicable regulations and procedures
Drive adoption of compliant clinical study execution practices throughout sponsor active in clinical studies including research and testing of products involving human beings
Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting.
Ensure the clinical studies are conducted according to procedures including up to date and complete trial master files, regular review of data, and assurance that monitoring reports are completed within two weeks of visit date.
Ensure that monitoring plans are created and followed with monitoring documentation to support this included in the applicable Trial Master Files.
Act as Clinical Study Manager for designated clinical studies under the guidance of your Manager and may support other studies in this role as applicable.
Attend all required meetings and provide updates to team.
Support EDC user acceptance testing and training as applicable
Oversee and support the creation of the trial master file, regulatory binder, source documents, and investigational product ordering, shipping, and associated documentation
The Clinical Operations Senior Clinical Research Associate (CRA) is responsible for monitoring and leading the monitoring of clinical research studies involving human subjects from its inception to close-out according to budget and timelines.
Qualifies, Selects, Trains and Monitors internal and external study Investigators and study documentation.
May be the lead for site management and expected to communicate well with internal and external business partners including key opinion leaders.
Works on issues where analysis of situation or data requires review of relevant factors.
Typically acts as a lead, coordinating the work of Specialist or Coordinator, but is not a supervisor