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Author Topic: Clinical Research Associate - Hudson  (Read 1625 times)

Rich T.

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Clinical Research Associate - Hudson
« on: July 10, 2006, 04:56:32 pm »

Clinical Research Associate

Atrium Medical has an opening for an Experienced Clinical Research Analyst - Medical Device Experience a Plus!

Founded in 1981, Atrium is a privately held healthcare products company located in Hudson, NH. Atrium is a market leading manufacturer of breakthrough medical device technologies used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. More recently, Atrium is known for its high technology presence in coronary stents, minimally invasive intervention of peripheral blood vessels, state-of-the-art hernia repair, drug delivery research, hemodialysis access, and market leadership in facial plastic surgery. Atrium manufactures over 1,000,000 sterile medical products each year which are distributed to over 60 countries. Maintaining a commitment to innovation in research, market development and manufacturing has enabled the company to excel in many global medical device markets. With more than two decades of experience, Atrium has been an innovator of new technologies designed to meet the clinical needs of the patient. Whether it is chest drainage, drug delivery, drug coated stents, or new ways to deal with vascular disease and general surgery, Atrium is working on a new and innovative ways to solve unmet clinical needs. Atrium offers a unique opportunity with exciting challenges for the qualified candidate.

Purpose:
To support clinical development and regulatory affairs by ensuring the conduct of quality clinical investigations and by evaluating and analyzing clinical data.  Responsible for the implementation and direction of clinical projects at the clinical sites. Travel to clinical sites to monitor clinical studies and coordinate investigations. To support research, development, regulatory affairs, manufacturing and marketing efforts by ensuring the conduct of quality animal investigations.

Specific Duties and Responsibilities:
*Monitor the clinical studies and coordinate clinical activities to ensure compliance with protocol and overall clinical objectives.
*Oversee the conduct of all clinical studies to ensure the quality and integrity of data.
*Analyze and evaluate clinical data from the clinical sites to endure completeness and accuracy.
*Coordinate and resolve all inquires and problems associated with the clinical investigations.
*Travel to clinical sites to supervise and coordinate clinical studies approximately up to 50% of the time.
*Prepare clinical reports as needed for regulatory submissions and when requested for presentations, monographs and publications.
*Participate in the development of clinical standard operating procedures and clinical guidelines.
*Plan, organize and participate in investigator meetings or ad hoc clinical advisory meetings as required.
*Maintain high level of professionalism through familiarity with clinical literature and participation in project meetings.
*Other duties that commensurate with associated training and experience

Qualifications:
RN,BS or equivalent plus a minimum of 2-5 years experience as a clinical research associate. Certification of a CRA is preferred. Knowledge of FDA/TPP regulatory requirements preferred. Attention to detail and good Follow-through skills. Knowledge of the clinical development process and good guidelines for clinical practices. Strong interpersonal skills. Outstanding oral and written communication skills. Possess an understanding of scientific terminology and surgical practices.
 
Drug screening is required.

Send resumes to Susan M. Duggan, sduggan@atriummed.com
(603) 880-1433 x5138
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