Field Clinical Engineer / Medical Research Engineer

Job Summary:
Working under general supervision, the Field Clinical Research Specialist provides field support of Clinical Research (research feasibility and IDE trials) including training, data collection, and implant/troubleshooting of products undergoing clinical trials, accurate technical service/troubleshooting of products, liaison between customers and company.

Job Functions:
•Oversee site qualification and initiation process, including scheduling monitoring activities with site personnel and overseeing subject screening and enrollment.
•Facilitate negotiation of contracts and budgets with sites.
•Plan, prepare, and distribute materials for investigator and coordinator meetings, and for study related training including implant procedure device preparation, implant surgical procedures, programming and patient education and device use testing.
•Attend implants. Provide assistance w/implant preparation, implant, and programming of company device implants & follow up.
•Respond to center issues and complaints rapidly. Troubleshoot and resolve problems on site and in collaboration with appropriate company personnel.
•Liaison between customers & the company regarding clinical research and product issues. This encompasses research studies, IDE clinical trials, and troubleshooting.
•Assist in query resolution process.
•Participate in development/review and distribution of study related documents including Case Report Forms (CRF's), study protocols, study manuals, and other study tools to investigational sites and review committees.
•Manage distribution, collection and tracking of regulatory documentation to ensure compliance at the sites for audit readiness.
•Facilitate submission of research for presentations, work with internal contacts & customers to prepare scripts, slides, overheads, power point presentations & manuscripts.
•Increasing responsibility for assisting with the conduct of clinical team meetings, including agenda preparation, minutes, and action item tracking.
•Forecast device needs of individual centers for project in collaboration with supply-chain.
•Oversee the device malfunction process and tracking; ensure appropriate safety reporting.
•Other duties as assigned.

Job Requirements:
•Detail oriented.
•Effective Interpersonal skills / Relationship Building skills.
•Effective oral and written communication skills.
•Understanding and application of clinical research principles.
•Working knowledge of electrical stimulation/HF technology/therapies.
•Intermediate application of FDA regulations and good clinical practices.
•Strong problems solving and decision-making skills.
•Ability to perform in a cross-functional team environment.
•Develops sufficient product/indication expertise to communicate directly with clinicians, staff, other departments, consultants, etc.
•This person will also be highly responsive and proactive.

Qualifications:
•Minimum, BS in the health/life sciences, study management or engineering.
•At least 3 years clinical research experience in clinical/scientific research, nursing, or medical device / pharmaceutical industry required.

Mile widziane
MS in the Healthcare/Life Sciences, Study Management or Engineering & experience in the management of class 3 devices will be a plus.