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 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
- Monitor data submitted on Case Report Forms (CRFs) or other data collection tools
- 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
- Participate in protocol development and clinical trial report writing
- 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 (QC) 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
Qualifications:
- University or college degree (life science preferred) or certification in a related allied health profession
- 3 years of Clinical Monitoring experience
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and in English
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision and good planning and organisation skills
- Valid Driver's License
Preferred Qualifications:
- Additional experience in a related field
- Local project coordination and/or project management experience
Physical Demands/Work Environment:
- 60-80% overnight travel required