Description
Fortrea's FSP team is seeking experienced Central based Sr. CRAs with 1+ year of device experience. The role involves site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Senior CRA II is responsible for:
- Site monitoring and site management
- Implementing project plans
- Leading projects of limited scope
- Acting as Local Project Coordinator or Lead CRA
- Ensuring study staff have proper materials and instructions
- Protecting study patients by verifying informed consent procedures and protocol requirements
- Ensuring data integrity through source document review
- Monitoring data for missing or implausible entries
- Managing travel expenses efficiently
- Preparing accurate and timely trip reports
- Managing small projects under a Project Manager/Director
- Serving as lead monitor for a protocol or project
- Reviewing project progress and initiating actions to achieve targets
- Organizing presentations at Investigator Meetings
- Participating in protocol and Case Report Form development
- Interacting with internal work groups
- Acting as contact for clinical trial supplies and vendors
- Managing registry aspects as prescribed in project plans
- Conducting feasibility work and Quality Control visits
- Recruiting investigators and preparing EC submissions
- Negotiating study budgets and assisting with agreements
- Tracking Serious Adverse Event reporting
- Performing CRF reviews and query resolution
- Assisting with training and development of new employees
Qualifications:
- University or college degree in life sciences or related field
- Certification in a related allied health profession
- 3+ years of Clinical Monitoring experience
- Thorough knowledge of regulatory requirements
- Understanding of the drug development process
- Fluent in local office language and English
Experience:
- Advanced site monitoring skills
- Advanced study site management skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Valid Driver's License
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight
- Work is performed in an office environment with exposure to electrical office equipment
- Occasional drives to site locations with occasional travel both domestic and international
Target Pay Range: $130-133K