Description
Description of Duties:- Assists with successful conduct of assigned studies consistent with R&D and Marketing plans.
- Includes interfacing with representatives from key functional groups including Field Clinical Operations, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups.
- Assists in preparation of study materials and training of investigators, center staff and field staff.
- Writes the monitoring plan. Coordinates and conducts monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents.
- Reviews clinical data/information and oversees data correction. Assists clinical research specialists in providing interim and final reports and presentations.
- Provides input to study budgets and project plans.
- Assists clinical research specialists by providing sections of Investigational Plan or protocol as needed.
Key skills:
- Associates Degree minimum, with 4-6 years clinical research experience as a CRA or
- Bachelors (Four year) degree with 3-5 years clinical research experience as a CRA
- Experience managing multiple sites and intra-project initiatives
- Study start up experience
- IDE study experience
- Ability to travel 25%
- CRO/vendor management a plus
- Medical device experience a plus
- Expertise with GCPs and regulatory compliance guidelines for clinical trials.
Rate: $45 - $50 an hour (W2 or C2C)
Location: Minnesota
Duration: 12 Months
Please send me your most up to date Resume if you would like to be considered for the position.
To find out more about Real please visit www.realstaffing.com