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 activities 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 source documents to ensure data integrity
- Monitor data for missing or implausible entries
- Perform monitoring tasks efficiently, according to SOPs and established guidelines
- 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 case report form creation
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and vendors
- Track and follow up on Serious Adverse Event (SAE) reporting
- Independently perform CRF review and query generation
- Assist with training and mentoring new employees
Qualifications:
- University or college degree in life sciences or related field, or certification in a related allied health profession
- Three years of clinical monitoring experience
- Thorough knowledge of regulatory requirements and the 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, organization, and communication skills
- Valid driver's license
Physical Demands/Work Environment:
- Travel requirements: 60-80% overnight