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Senior Clinical Research Specialist – Structural Heart
| Company | Medtronic |
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| Location | Blaine, MN, USA |
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| Salary | $105600 – $158400 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree with a minimum of 4 years of clinical research experience
- OR Advanced degree with 2 years of clinical research experience
Responsibilities
- Provide echocardiography and imaging input to quality, safety, clinical research and research and development
- Develop and support educational materials to train sites on data quality and completeness
- Reviewing echo core lab reads during screening committee calls
- Perform pre-screening analysis
- Coordinate and work with echo and CT core labs supporting trials
- Execute clinical research education activities related to echocardiography
- Perform detailed analysis of imaging
- Participate in development of trial and research definitions related to echocardiography
- Review trial protocols, CRFs and other documents for echocardiography related appropriateness
- Review patient data to ensure study protocol inclusion/exclusion criteria is met and patient is appropriate candidate for therapy
- Oversees, designs, plans and develops clinical evaluation research studies
- May be responsible for clinical supply operations, site and vendor selection
- Builds and maintains optimal relationships and effective collaborations with various internal and external parties (i.e., clinical site physicians, nurses, echocardiographers, sonographers, etc.)
- Assists with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies
- Provides support and training for clinical study teams, physicians, and cross-functional partners to assure data integrity and protocol compliance. Assists in preparation of study materials and/or training and tracks and maintains study documentation.
- Performs data review, reviews data discrepancies, generates reports
- May interface with representatives from key functional groups including Product Development, Therapy Development, Manufacturing, Sales & Marketing, Distribution, and Regulatory Affairs
- Assists clinical management with other duties as requested
Preferred Qualifications
- Advanced Cardiac Sonographer Credentials strongly preferred
- Experience in CT and other multimodality imaging
- Experience in assisting echo in structural heart procedures
- Competent in advanced echo imaging modalities (3D, MPR, strain) in various pathologies
- Experience in training and education
- Degree in life sciences, or related medical/scientific field.
- Experience conducting/working on clinical studies and managing clinical trial data review
- Clinical Research experience at Medtronic or within a medical device industry in structural heart area
- Strong knowledge of clinical research methodologies, including study design, implementation, and reporting.
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
