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Job #03152

About our client Our client is the first fully integrated CRO and core imaging services company offering a full range of trial management, consulting and imaging services to pharmaceutical, biotechnology, and medical device companies. They have two offices in NH and MO. This CRA role will be based in Chesterfield, Missouri. They boast a fully integrated core imaging lab, which enables complete study coordination from the site to CRO and Imaging centers. Position Location Clinical Research Associate Chesterfield, Missouri Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor all types of clinical trials, ensuring adherence to Good Clinical Practices, Investigator integrity and compliance with all study procedures 2) Assist with identifying and contacting potential investigators 3) Ensure adequacy of clinical research staff/facilities with regard to company/sponsor SOPs and global regulatory requirements 4) Identify issues and problems for resolution by the Lead CRA or Project Manager 5) Prepare for and conduct site initiation visits 6) Ensure completion of regulatory documents and review Investigator’s tasks 7) Coordinate shipment of study-related materials 8) Assist in preparing for and attending investigator meetings 9) Assess overall investigational site performance 10) Ensure Investigator’s adherence to protocol and initiate action for proactive issue resolution 11) Ensure regulatory documents are available, current and organized 12) Review CRFs for completeness and accuracy and ensure that corrections are completed appropriately 13) Perform source document verification 14) Review adverse event incidence, both serious and non-serious and follow company/sponsor reporting procedures 15) Review Data Clarification Form resolution 16) Ensure clinical trial materials’ accountability 17) Prepare trip reports and follow-up with sites recommending corrective action 18) Maintain regular telephone contact with the site 19) Maintain study-specific tracking files as required for each project 20) Maintain written correspondence with the site as required by each project 21) Appraise the Lead CRA/Project Manager about site and study status 22) Perform in-house clinical CRF reviewing, if applicable 23) Resolve all outstanding data clarification forms 24) Retrieve any remaining CRFs 25) Ensure regulatory documents are available and complete 26) Review record retention requirements 27) Ensure clinical trial material accountability and clinical trial material return and disposal 28) Secure and review Investigator’s final study report 29) Perform administrative duties including attendance at company staff meetings, project team meetings, training and orientation sessions 30) Maintain awareness of overall development in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, etc 31) Perform other assigned activities Requirements 1) RN, BSN, BS/MS, or BA or an equivalent degree in a scientific or Healthcare field plus 2 years healthcare or research related experience 2) Direct clinical trial experience in and knowledge of procedures for monitoring clinical trials 3) Excellent communications skills (verbal and written) 4) Above average interpersonal and organizational skills 5) Ability to work independently, prioritize and actively seek inputs 6) Ability to solve problems and work within a matrix team environment 7) Proficiency in computers 8) Willingness to travel