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
- 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
- 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
- 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
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.
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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