Description
The Senior CRA I is responsible for site monitoring and site management, ensuring the implementation of project plans, and acting as a leader for projects of limited scope.
Responsibilities:
- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and liaison with vendors
- Manage site management as prescribed in project plans
- 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
- Review data for missing or implausible data
- 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, prepare EC submissions, and notify regulatory authorities
- 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, or certification in a related allied health profession
- 3 years of relevant clinical research experience in pharmaceutical or CRO industries
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and English
Experience:
- 3 years of Clinical Monitoring experience
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision and good planning and organization skills
- Good computer skills and advanced verbal and written communication skills
- Ability to train and supervise junior staff
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight