Clinical Research Associate (CRA)

Website AMF4SR Alfred Mann Foundation

Pioneering Innovative Solutions

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.


• 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.

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