Sr. Clinical Research Associate

Sr. Clinical Research Associate - Medical Device

A major client of Kelly Scientific Resources has an immediate need for a Sr. Clinical Research Associate in the Boulder area. This is a project-based position tentatively scheduled for the next 6 months. If you are interested, please see the description below and submit your resume and references to our recruiter. Position Summary: Support the development of new technologies, new products, extended product claims, and post-market clinical research and surveillance. Participate in all aspects of ongoing clinical research programs by planning, developing, and writing clinical protocols; budgeting; recruiting and training investigators; site coordination; analysis of clinical progress; prepare clinical portion of PMA, 510k, Design Dossier, and IRB/EC submissions. Primary Responsibilities · Serve as a clinical expert project leader for highly complex projects or regulated trials to develop clinical strategies that support corporate and departmental objectives. · Provide clinical and technical feedback to product development teams. · Design, initiate, conduct, and close out all company sponsored trials. · Develop study protocols, case report forms, and informed consent forms ensuring the study will produce sound and thorough data to support the approval process and adherence to FDA/GCP/ICH requirements. · Serve as Clinical Affairs representative on assigned project teams acting as patient advocate for technical safety of all devices. · May be responsible for management and development of 1-2 employees. · Develop and maintain professional relationships with academic and community-based surgeons to assure good clinical input on product development process, marketing, and field sales force. Minimum Qualifications: · A minimum of a Bachelor?s degree (Life Sciences is strongly preferred) plus 5 years of relevant experience. · Three (3) years experience in medical device or drug clinical research is desired . · Experience with GLP, GCP, or GMP is required. · Strong technical or clinical background is required. · Effective written and verbal communication skills in the area of clinical applications. · Knowledge of medical device design control, technology development, product development, and claims development. · Knowledge of operating room and surgical procedures. · In-depth experience of FDA and international regulations concerning the conduct of clinical studies. · Working knowledge of statistics and statistical methods. · Ability to travel up to 25% of the time. This is a contract position through Kelly Scientific Resources, working Monday to Friday, 1 st shift. Pay will be based on experience. If interested please apply online. Local candidates are highly desired . Kelly Scientific Resources (KSR) is the leading scientific and clinical research staffing company in the world. We employ more than 700 clinical research professionals and 4,500 scientists on an average workday on a temporary, project and full-time basis in a broad spectrum of industries and disciplines. KSR has more than 100 locations in North America, Europe and the Pacific Rim. Please visit us at www.kellyscientific.com to learn more. Kelly Services is an Equal Opportunity Employer