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Sr. Clinical Research Associate (Sr. CRA)
Sunnyvale, CA

ArthroCare Corp. is a multi-business medical device company that develops products based on its pioneering Coblation(R) technology. The benefits of Coblation technology provide an answer to the challenges of soft tissue management in any surgical specialty where controlled and efficient ablation is of value. Current applications include: Arthroscopic Surgery, Spine Surgery, Dermatologic Surgery, Ear, Nose & Throat Surgery (ENT), and General Surgery.

Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development.
Summary: Responsible for the initiation, design, development, execution, and implementation of clinical research studies, which are utilized to support new product submissions as well as refinements to current products, and expansion of product indications for use. Support all regulatory submissions to the FDA including 510(k), investigational device exemptions (IDE), pre-market approvals (PMA), and technical file submissions international regulatory bodies. Support clinical data management activities including database design and data analysis.
Essential Duties and Responsibilities include but are not limited to:
 Design, coordinate and implement all activities required to initiate, monitor, and close clinical studies and marketing evaluations that are well designed and scientifically valid.
 Design and manage clinical databases for data entry, storage and analysis.
 Provide feedback to the product development process related to user and/or clinical requirements.
 Support regulatory filings by planning, executing and writing reports of clinical studies as required.
 Maintain substantial knowledge of the general rules and regulations governing clinical studies.
 Consult and interact with inside and outside experts, especially study investigators and key physician consultants.
 Support the writing and submission of articles to peer-reviewed journals and scientific conferences, and internal literature management.
 May be required to perform other duties as assigned.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.

Education and Experience:
• AA degree required (RN or Biology/Science major a plus) plus 3+ years of related experience with a strong understanding of specified functional area(s) or an equivalent combination of education and work experience. Bachelor’s degree preferred. Clinical research experience in the medical device Industry highly desired.
• Wide application of clinical principles, practices, and procedures.
• Strong understanding of business unit functions and cross group dependencies/ relationships.
• Will perform job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Participates in the development of less experienced staff by setting an example, providing guidance and offering counsel. Participates in determining goals and objectives for projects. May interact with vendors.
• Plans and organizes non-routine tasks with manager approval. Participates in initiating or maintaining work schedule, and in establishing priorities of work assignment.
• Supports decisions related to study design and conduct in cooperation with internal staff and outside investigators. Decisions regarding day-to-day activities will be made in collaboration with manager.
• Selection of study sites and investigators will be made in conjunction with Business Unit Marketing and Senior Management inputs. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• Knowledge of the general principles of Good Clinical Practice (GCP) highly desired. Excellent verbal communication and writing ability are mandatory. Must be assertive and able to work independently.

Physical Demands: Significant amounts of traveling (up to 30%) may be necessary. The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of the job.

For consideration of this and other opportunities please visit our career center at:
http://careers.arthrocare.com


Equal Opportunity Employer
www.ArthroCare.com

• Location: Sunnyvale
• Principals only. Recruiters, please don't contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.