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WHAT
IN
Respiratory Solutions-Pre-Market Clinical Research Associate II 09-2061
Job
Covidien
US
-
Boulder,
Colorado
Job Code - 9378D5210A32F66F
Position - See Job Description
Job First Active on: Wednesday, November 04, 2009
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JOB DESCRIPTION: Respiratory Solutions-Pre-Market Clinical Research Associate II (09-2061)
Pre-Market Clinical Research Associate II
Nellcor Puritan Bennett, now the Respiratory and Monitoring Solutions (RMS) business unit of Covidien, formerly Tyco Healthcare, is recruiting for the Pre-Market Clinical Research Associate II (CRAII) position. RMS systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.
For more information, visit us as www.covidien.com.
The Clinical Research Associate II is responsible for the planning and execution of high quality pre-market clinical studies that will be used for 510k, IDE or PMA submissions. The Clinical Research Associate II works closely with R&D project teams (often as a core team member) to define the clinical strategy for the project and ensure the development of clinically relevant products. The Clinical Research Associate II has strong experience in developing clinical strategies and/or plans, protocol development and execution, and documentation of clinical studies. The position will be responsible for increasing the RMS division’s ability to demonstrate product safety and effectiveness, as well as improve customer satisfaction of our medical devices in development. All activities will be conducted in accordance with Government Regulations (FDA, CE, ICH etc), Good Clinical Practices, and Department Operating Procedures (DOP). Working with the Clinical Directors and the Clinical Programs Manager, the Clinical Research Associate II participates in clinical strategy for various product development projects. The Clinical Research Associate II implements the project clinical strategies through their work on project teams and execution of in-house and/or field clinical studies.
Pre-Market Clinical Research Associate II Duties:
• Represents the Clinical Affairs Department on new product development programs and other multi-functional teams.
• Independently develops Clinical Validation Strategies, Clinical Study Plans, and Clinical Protocols to evaluate the accuracy and clinical performance/acceptance of RMS products prior to product release.
• Works with senior Clinical Staff to strategically plan, implement and conclude complex clinical studies in support of project timelines/market release goals.
• Is responsible for the accuracy, completeness and regulatory compliance of all clinical study results for their assigned programs
• Conducts and observes product testing and operation of equipment at RMS and customer/clinical sites.
• Utilizes the tools (including computer s/w and h/w) needed to perform job duties.
• Applies advanced understanding of Federal Regulations and international standards under which clinical studies of medical devices are conducted.
• Applies critical thinking to complex clinical study problems.
• Designs and achieves personal training/education goals related to continued development of technical knowledge.
• Acts as clinical and/or technical expert/liaison on matters affecting accuracy and clinical performance of RMS products.
• Writes clear, succinct clinical study documents to describe complex technical material.
• Assist in the development and maintenance of SOPs and guidelines to assure group operations, internal files, site files and field data conform to Good Clinical Practice regulations, appropriate sections of 21 CFR and internal policies.
• Coach, mentor, and advise junior Clinical Affairs staff in performance matters.
REQUIREMENTS - QUALIFICATIONS: Respiratory Solutions-Pre-Market Clinical Research Associate II (09-2061)
Qualifications:
• Bachelors Degree in Science/Medical/Health related field required.
• 4+ years Clinical Research experience.
• 2+ years Medical Device experience.
• Clinical experience preferred (Registered Respiratory Therapist or Registered Nurse).
• Experience translating medical industry needs and knowledge to product opportunities.
• Able to read and interpret technical procedures and regulatory requirements.
• Knowledge of applicable regulations and standards for medical devices.
• Computer literate with above average knowledge of Microsoft Office applications Outlook, Word, Excel and Microsoft Project software.
• Possesses strong verbal and written communication skills.
• Detail oriented and well organized.
• Able to work effectively on a cross-functional team.Able to work effectively on a cross-functional team.
• Skills in general business management, planning, analyzing and decision making, leadership and communication.
• Ability to independently set and manage multiple priorities.
• Travel up to 35% may be required.
EEO/AA
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