Description
The Senior Clinical Research Associate II (Sr CRA II) is responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, and assumes line management responsibilities as assigned.
Responsibilities:
- Conduct site monitoring and site management for clinical studies
- Ensure study staff have received proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements are adhered to according to regulatory requirements
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Travel, including air travel, may be required
- Prepare accurate and timely trip reports
- Manage small projects under the direction of a Project Manager/Director
- Serve as lead monitor for a protocol or project
- Review progress of projects and initiate actions to achieve target objectives
- Organize and make presentations at Investigator Meetings
- Participate in protocol development and writing clinical trial reports
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and other suppliers
- Undertake feasibility work and conduct Quality Control visits
- Recruit potential investigators and prepare EC submissions
- Negotiate study budgets with potential investigators
- Track and follow-up on Serious Adverse Event (SAE) reporting
- Independently perform CRF review and query generation
- Assist with training and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree in a related allied health profession
- 3-4 years of Clinical Monitoring experience
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and English
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision and prioritize workload
- Good planning and organization skills, computer skills, and verbal and written communication skills
Preferred Qualifications:
- Knowledge of company SOPs regarding site monitoring
- Experience in a related field (medical, clinical, pharmaceutical, etc.)
- Local project coordination and/or project management experience
- Ability to maintain confidentiality of data and information
- Demonstrated ability to conduct clinical operations activities effectively and efficiently