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SUMMARY OF POSITION:
The Clinical Research Associate II is responsible for providing clinical guidance, strategy and support for the development of new technologies, new products, extended product claims and post-market clinical research and surveillance.
ESSENTIAL FUNCTIONS:
•Maintain the professional competency, knowledge and skill necessary for the successful performance of assigned duties and responsibilities.
•Maintain adequate knowledge and understanding of current scientific literature required to support all product lines and related clinical studies.
•Establish and maintain effective relationships with external physician advisors and clinical investigators and applicable research staff.
•Develop clinical study protocols, seeking input as needed from R&D, Marketing, Medical Affairs and Regulatory departments.
•Assist Institutional Review Boards (IRB) submissions for clinical studies.
•Perform site/investigator evaluations, initiations, monitoring and closeout visits as necessary.
•Maintain clinical project files to assure compliance with internal procedures and Federal regulations.
•Assist internal departments and study investigator(s) as needed to write final reports for clinical studies.
•Assist Manager of Clinical Affairs in maintaining Standard Operating Procedures for the department.
•Serve as Clinical Study Project leader and serve as the Clinical Affairs representative on assigned project teams.
Requirements:
MINIMUM REQUIREMENTS:
Education and Experience:
•A minimum of an Associates degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 4 years relevant experience which includes at least two (2) years experience in medical device/drug customer relations, clinical research; or a Bachelors Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus 2 years experience in medical device/drug customer relations, clinical research required.
•A Graduate degree with a demonstrated research background is preferred.
•Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) is preferred.
•Prior participation in all facets of clinical studies required.
•Strong technical or clinical background required.
Skills/Qualifications:
•Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology.
•Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
•Effective analytical and problem solving.
•Ability to coordinate and lead multiple projects simultaneously.
•Knowledge of FDA regulations concerning the conduct of pre-clinical and clinical studies.
•Knowledge of international regulations for clinical studies.
•Effective knowledge in searching medical literature and databases for clinical and technical information.
•Effective skills in MS Excel, PowerPoint, Word and internet search engines.
•Knowledge of computerized databases for the maintenance of scientific data.
•Working knowledge of statistics and statistical methods.
•Strong command of Good Laboratory Practice (GLP) regulations.
•Ability to train others.
•Ability to work with a minimum of supervision.
•Ability to work in a highly matrixed team environment.
Skills/Competencies:
•Ethics and Values
•Functional Technical Skills
•Customer Focused
•Interpersonal Savvy
•Managing and Measuring Work
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
Reports to Manager or Director of Clinical Affairs. Interacts cross functionally with R&D, Marketing, Medical Affairs and Regulatory departments.
To apply online, please use the following link:
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