Kelly Scientific Resources is currently seeking candidates for a Sr. Clinical Research Associate for one of our top clients in Minneapolis, MN. This is Direct Hire position.
As a Sr. Clinical Research Associate, you will be responsible to satisfy applicable regulatory standards and internal requirements for worldwide clinical studies.
Assists with successful conduct of assigned studies consistent with R&D and Marketing plans. This includes interfacing with representatives from key functional groups including Product Development, Manufacturing, Sales, Marketing, Distribution, and Regulatory Affairs.
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 study managers in providing interim and final reports and presentations.
Provides input to study budgets and project plans.
Assists study manager by providing input to sections of Investigational Plan.
Assists study manager in writing Clinical Reports.
Assumes project management responsibility for smaller studies.
Assists study manager/statistician in writing of abstracts/manuscripts.
Reviews and approves center activation documentation.
Educational and Experience Requirements:
Bachelor’s degree (technical or non-technical) Technical degree defined as engineering, biological sciences or related medical/scientific field preferred.
Master’s degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.
2-5 years’ experience directly supporting clinical research or similar experience in a medical/scientific area.
High attention to detail and accuracy
Advanced written and oral communication skills
Expertise with GCPs and regulatory compliance guidelines for clinical trials
Demonstrated ability to work effectively on cross-functional teams
Position requires 30% travel