Job Summary:
The Principal Field Clinical Specialist will communicate with clinical trial sites, train clinical trial sites, and support CLAAS AcuFORM LAAO procedures. This role has broad geographic responsibilities including the entirety of the US , potentially EU other non-US travel. This role will also help lead the effort to train trial site personnel on TEE, and CT imaging as it pertains to the LAAO procedure and CLAAS AcuFORM device planning and execution.
Scope: Stays current on area specific literature, trends in left atrial appendage closure and clinical research related information. Maintains overall clinical research competency. Understanding of SOPs, ICH, FDA, IRB and local regulations. While Conformal Medical is based in Nashua, NH, we are open to candidates throughout the continental US. Candidates must be located near a major US airport hub.
Essential Functions:
- Training sites and implanters on CLAAS AcuFORM System as investigators in the CONFORM Trial. Site support of future Conformal trial activity as needed.
- Collaborating with site staff on subject selection (Eligibility Criteria).
- Screening images (CT and TEE) for potential patients in the CONFORM Trial.
- Trains on and maintains knowledge of clinical trial protocols, Clinical Department standard operating procedures, and compliance toward the regulations of world-wide regulatory bodies to meet corporate and departmental objectives.
- Educates clinical investigators on clinical trial protocols, clinical process, and investigational products and features.
- Assist in the delivery of procedural training with physicians and medical staff.
- Support territory and other Therapy Development efforts to build strategic partnerships that will further area and organizational objectives.
- Educates clinical investigators on clinical trial protocols, clinical process, and investigational products and features.
- Supporting sites and implanters before, during and after CLAAS AcuFORM implant.
- Completing necessary study-related documents (procedural)
- Assist with trial device accountability and inventory reconciliation.
- Other duties as assigned.
- Travel: 75%.
Required qualifications:
- 5+ years of experience in medical device clinical support.
- ~3 years Left Atrial Appendage Occlusion (LAAO) industry clinical experience with LAAO implant experience of 250+ implants.
- Highly computer literate: excellent knowledge of Microsoft Office suite (Word, Excel, PowerPoint, Outlook, etc.).
- Proficiency with imaging software (3 Mensio) or similar platforms.
- Excellent organizational skills, ability to handle multiple tasks to meet deadlines with attention to detail.
- Strong interpersonal skills as well as willingness to work within a team-oriented environment.
- Proven ability to manage multiple, geographically diverse accounts and necessary travel.
- Problem solving capability and highly collaborative with teammates and other functions within Conformal.
- Customer relationship development and procedural skill development experience.
- Knowledge of cardiovascular imaging is required (e.g. Echocardiography (TEE and TTE), coronary angiography, Computed tomography (CT)).
Preferred Qualifications:
- Intra Cardiac Echo (ICE) imaging experience is preferred.
Education Requirements: Requires BA / BS in the science/health care field or equivalent related experience.