Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

• 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.

• 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
• 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.

• 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

• Minimum, BS in the health/life sciences, study management or engineering
• At least 3 years clinical research experience in class III medical device experience
• Operating room or cathlab experience a plus.
• Excellent communication skills
• Valid passport/comfortable doing travel outside the US

• MS in the Healthcare/Life Sciences, Study Management or Engineering
• Experience in the management of class 3 devices 

• General office environment, and includes 50% or more travel to research laboratory or hospital settings, meetings and/or other company facilities. There is the potential for exposure to blood borne pathogens and other potentially infectious materials. 
• Initially extensive international travel. Or this job is open to candidates living in  Poland, Germany or Italy.