Clinical Research Associate I

Location:
Ft. Lauderdale, FL

Position Description:
Under the direction of the Director of Clinical Research will develop and maintain the necessary protocols to support clinical trials.

Departmental Responsibilities:

• Develop and maintain a database structure for the storage of all clinical data; retrospectively populate database with all available clinical information
• Implement appropriate protocols to prospectively populate database
• Responsible for review and collection of clinical data
• Ensure the scientific integrity of clinical data
• Moderate and maintain online surgeon and CTS (Clinical Technical Specialist) forum for dissemination of case-specific information
• Assist developing research protocols, obtaining IRB approval and monitoring protocols
• Assist with the collection, tracking and review of regulatory documents
• Assist with preparation of presentations, abstracts and manuscripts
• Establish and maintain strong relationships with Study Coordinators and PIs
• Track site questionnaires and produce status reports of same as requested for Director of Clinical Research
• Acts as the site contact

• B.S degree or (R.N.) with a minimum of 3 years experience working in clinical research capacity; combination of experience and education is acceptable
• Knowledge of FDA regulatory requirements
• Excellent organization skills and initiative with the ability to drive processes with minimal supervision
• Strong proficiency with MS Office: Word, Excel and PowerPoint
• Excellent written and oral communication skills
• Ability to travel 15%