Description
Responsibilities:- Provide key clinical support for the operation and execution of clinical trials for clinical programs
- Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments
- Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both during clinical trial conduct
- Has had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program
- Leads study management team meetings and teleconferences with study vendors
- Manages study-specific CROs and vendors and contract CRAs as appropriate
- Performs monitoring of sites as required by needs of project with minimal guidance or supervision
- Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance
Requirements:
- BA/BS in science-related field
- Minimum of 5 years years work experience as a CRA or CRA/CTM combination of relevant related work experience
- Demonstrated thorough understanding of FDA regulations and GCP
- Demonstrated skill in managing multiple tasks simultaneously, with attention to detail
- Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc.
- ***Ability to travel is important as the position could require approximately 25% time spent in business travel
To find out more about Real please visit www.realstaffing.com