Description
The Senior CRA I is responsible for site monitoring and site management, ensuring clinical studies are conducted according to Standard Operating Procedures and Regulatory Guidelines.
Responsibilities:
- Conduct site monitoring, including routine monitoring and closeout of clinical sites
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors and perform other duties as assigned
- 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
- Review data for missing or implausible data
- Monitor data for quality and 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
- Responsible for registry management
- 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 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 life science or related field
- Certification in a related allied health profession or nursing certification
- 3 years of relevant clinical research experience
- Thorough knowledge of regulatory requirements
- Understanding of the drug development process
- Fluent in local office language and English
Experience:
- 3 years of Clinical Monitoring 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
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight