Clinical Principal Specialist
Spectranetics - Colorado Springs, CO

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The Principal Specialist is responsible for all aspects of pre-clinical and clinical trial management for both domestic and international clinical trials. This position will both lead and work with a team from pre-clinical design through clinical evaluation as needed for the efficient execution of device commercialization in both interventional peripheral and cardiology applications. Although the position is within the Clinical Affairs department, the Principal Specialist must have adequate experimental research design skills to drive clinically relevant product review.

Key Duties and Responsibilities:
  • Lead and/or assist with the creation of pre-clinical and clinical studies including study protocols, data forms, patient consent forms, research coordinator’s study site guidelines, and other worksheets, materials or forms needed for execution of SPNC clinical trials.
  • Collaborate on R&D project teams to provide clinically relevant design input.
  • Perform all duties required in the clinical research process including site screening, site qualification and initiation visits, training; monitoring and site close-out visits as needed.
  • Track all documentation and expedite completion of all requirements required for pre-clinical and clinical study completion.
  • Interface with investigating physicians, engineers, Contract Research Organizations (CRO) and site research coordinators to ensure complete, accurate and timely submission of data. Create positive working relationships with site personnel
  • Review completed study data forms, enter data, and conduct periodic validations of database for accuracy.
  • May be the primary contact person for domestic and international clinical trials.
  • Organize and lead clinical investigator meetings when necessary.
  • Actively involved with the preparation of IDE’s, 510 (k)’s, PMA submissions to FDA. May lead some efforts
  • Perform other duties as assigned.
  • Independently drive publication activities for clinical trials
  • Mentor junior staff on research / clinical trial process and procedures. Provide clinical knowledge and scientific knowledge expertise to the development of junior staff
  • Understand and interpret technical, scientific and clinical information and apply that understanding to product approval activities
Education/Experience Necessary:

Bachelor’s Degree or equivalent scientific research post-graduate training (MS or PhD preferred). Three to five years of research experience (bench and/ or clinical) either in medical device or similar industry required. Training/work experience in cardiac catheterization labs is a plus. Must be familiar with cardiovascular devices and procedures and have actively participated in medical device clinical trials or conducted research as part of post graduate training.

Special Requirements:

Must have excellent communication skills and effective interaction with members of top management as well as establish external relationships within the industry. Must have a working knowledge of cardiovascular anatomy, physiology, and mechanisms of cardiovascular disease. Must be familiar with the coronary interventional and peripheral interventional lab environments and current treatment options or have other clinical and/or clinical trial experience that fulfills this requirement.

Must have an understanding of Good Clinical Practice requirements and ICH guidelines. Experience with computers and various databases highly desirable. He/she must be assertive, persistent, detail oriented, and comfortable interacting with R&D engineers, regulatory specialists, marketing, physicians and support personnel.

Work in an office environment. Work in hospital and lab environments. Overnight travel to various states/internationally for start-up’s and professional meetings will be required. Travel is estimated to be 25-40% of the time depending on the phases of the trial.

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The Spectranetics Corporation was founded in the 1980s on excimer laser technology and today markets the only Excimer Laser System approved...