To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03580

About our client Our client is a young venture-backed medical device company headquartered in Massachusetts that is focused on the development of innovative interventional cardiology technologies for patients suffering with complications arising from congestive heart failure. The company has an experienced management team, world class financing and excellent momentum in their clinical programs. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure clinical trial compliance with federal regulations, GCPs, ICH guidelines and company SOPs 2) Assist the Clinical management with the development, negotiation and execution of the site contract, budget and payment plan, with final approval from them 3) Serve as key site management team member to internal and external partners and provide on-call help for sites as well as on-going site training 4) Participate in the site qualification and initiation process including scheduling monitoring activities with site personnel 5) Manage device accountability, inventory, distribution and oversee device complaint/malfunction process and tracking 6) Assist the Clinical management with development, approval and distribution of study-related documents including CRFs, study protocols, amendments, monitoring plan, study manuals and other study tools 7) Manage the development and maintenance of clinical trial documents, processes and systems according to goals and budget 8) Manage budget and payments for investigative sites and contract organizations 9) Oversee subject screening and enrollment at assigned clinical sites 10) Assist in planning, preparing and distributing materials for Investigator and Coordinator meeting and study-related training 11) Manage distribution, collection and tracking of regulatory documentation to ensure compliance at sites and sponsor central file and for audit readiness 12) Track and report progress of studies including patient enrollment/screening, data collection, adverse event documentation and FAQs 13) Assist in query writing and resolution process 14) Identify and gather missing or incomplete data from the investigational sites 15) Write or contribute to preparation of SOPs, consent forms, study guides, CRFs and any other clinical research-related documents 16) Assist the Clinical Manager in core lab activities and data monitoring committee responsibilities 17) Prepare Clinical Risk/Benefit Analysis (CRBA) under the direction of clinical management 18) Assist in developing and/or maintaining clinical infrastructure such as the drafting or reviewing SOPs and work instructions Requirements 1) Bachelor’s degree in a scientific or healthcare-related discipline 2) 5 years of experience as a CRA in the medical device industry 3) Experience in conducting pre-study, initiation and closeout visits (site management of leading research centers and institutions) 4) In-depth knowledge of FDA regulations and ICH GCPs 5) Proficiency in Microsoft applications (EDC experience an asset) 6) Excellent organizational and communication (written and oral) skills 7) Ability to work with minimal amount of supervision 8) Superb multi-tasking skills and ability to manage shifting priorities 9) Willingness to travel internationally (up to 30%) to South America and Europe