Nonin Medical, Inc. is a rapidly growing international medical device manufacturer that has been designing and distributing high quality medical monitoring devices since 1986. Headquartered in Plymouth, MN, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere.
The Sr. Clinical Specialist is responsible for determining the clinical research strategy for Nonin products for determination of safety and effectiveness and in support of clinical initiatives. These activities shall be conducted in compliance with applicable clinical and regulatory standards and in alignment with Nonin Medical corporate objectives.
Essential Job Functions:
- Establish clinical research strategy and tactics by business area and by product.
- Design, plan and implement the overall direction of clinical research projects.
- Establish /maintain policies and procedures that detail the conduct of required clinical activities at Nonin Medical Inc.
- Recruit and qualify clinical Investigative sites.
- Prepare and report on the status of clinical investigations internally and externally.
- Prepare IDE, IRB, and other documentation as required by the clinical investigation and regulatory requirements.
- Analyze data acquired during the course of the clinical investigation, prepare reports and presentations based on clinical findings.
- Assist in achieving compliance with U.S. and International standards as they pertain to clinical and regulatory activities.
- Develop budget for area of assigned responsibility, including budgets for individual clinical studies.
- Coordinate and manage Clinical Research Organization (CRO) activities.
Required Education & Experience:
- 5-10 years experience in a medical device clinical research environment.
- BS in Nursing, Biological science, or related field.
Required Knowledge, Skills & Abilities:
- Proficient knowledge of medical terminology
- Ability to work and manage multiple projects in a medical device environment with minimal supervision.
- Significant knowledge of clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations .
- High attention to detail and accuracy.
- Outstanding organizational skills.
- Interpersonal skills to communicate effectively across multiple departmental lines, with clinical investigators and clinical investigative sites.
- Strong computer, software and database experience.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Able/willing to obtain required hospital credentialing to assure appropriate access to required areas of the investigational site.
- BSN RN
- Experience in the areas of anesthesiology, cardiology, pulmonology, critical care and/or emergency medicine
- CRA certification
- Ability to travel via plane and car up to 30% of the time.
- Ability to sit, stand, and/or walk for 8 hrs/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.