Clinical Research Associate (CRA)

Summary:
Responsibilities include the planning, execution and interpretation of medical device clinical research and data collection activities. This position plays a key role in the development and execution of pre-clinical, pilot and pivotal trials intended to support regulatory registration of new indications and new medical devices, as well as physician-initiated and company sponsored and grant funded clinical trials.

Brief description of job duties:

• Handles all duties related to the execution of Clinical Trials from protocol design to the final clinical study report for one or several studies.
• Coordinates all efforts for clinical trials both within the organization and through outside vendors involved in the clinical trials, e.g. central lab, CROs.
• Drives all aspects of the project management process from initiation, planning, execution, control to closure.
• Trains field clinical representatives and clinical sites on study protocols and investigational products.
• Provides back-up support for other projects on an as needed basis.

EDUCATION and/or EXPERIENCE:

• BS or MS degree in Life Sciences, Engineering or a related field
• 4-8 years of experience in medical device clinical trial management.
• Proven track record of effectively working with clinical sites.
• Clinical certification by SoCRA or ACRP
• Experienced in independently writing protocols and other technical documents.
• Experienced in planning investigator meetings.
• Strong knowledge of clinical study guidelines (FDA, ICH and GCP).
• Ability to travel as required.