Description
We are seeking a Senior CRA I to join our team, responsible for site monitoring and site management of clinical studies according to Fortrea and Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Senior CRA I will assure the implementation of project plans, function as a leader for projects of limited scope, and assume line management responsibilities as assigned.
Responsibilities:
- Conduct site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, and conduct of pre-study and initiation visits
- 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 and ensure data integrity
- Monitor data for missing or implausible data and ensure audit readiness at the site level
- Travel, including air travel, may be required (60-80% overnight)
- 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 and assist in establishing monitoring plans
- 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 as prescribed in project plans
- Undertake feasibility work and conduct Quality Control visits
- Recruit potential investigators, prepare EC submissions, and notify regulatory authorities
- Negotiate study budgets with potential investigators and assist with statements of agreements
- Track and follow-up on Serious Adverse Event reporting
- Independently perform CRF review and query generation and resolution
- Assist with training and development of new employees
- Coordinate designated clinical projects as a Local Project Coordinator
Qualifications:
- University or college degree (life science preferred) or certification in a related allied health profession
- Three years of Clinical Monitoring experience
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and in English, both written and verbal
- 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 and resolve project-related problems
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field (e.g., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing)
- Local project coordination and/or project management experience