Description
This is a small company with a start up environment.Reports to: Sr. Manager of Clinical Affairs
Essential Duties:
- Plans and assists in study start-up activities; site start up, initiation, and close out
- CRO and vendor management; contract negotiations and provide input on allocation of trial budget
- Develops SOPs and related study protocols
- Mentors Jr. CRA - co-monitoring visits, regulatory submissions, etc
- Travels to domestic and international sites as required (approx 25%)
Requirements:
- B.S. in a scientific discipline
- 4+ years experience as a Clinical Research Associate
- 3+ years with clinical trials in medical device industry
- CRO/vendor management and prior monitoring experience
- Background in women's health is a huge plus
- Experience writing or assisting with regulatory submissions to FDA (PMA, 510(k))
- Domestic AND International clinical trial experience
- Ability to travel as required: 25 % approx
To find out more about Real please visit www.realstaffing.com