Description
We are seeking a Senior Clinical Research Associate II (Sr CRA II) to work on a dedicated sponsor project. As a Sr CRA II, you will be responsible for Risk-based Monitoring (RBM) and site management for clinical studies according to sponsor Standard Operating Procedures and Regulatory Guidelines.
Responsibilities:
- Conduct routine monitoring and close-out of clinical sites, maintenance of study files, and pre-study and initiation visits
- Liaise with vendors and manage study 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 source documents to ensure data integrity
- Monitor data for missing or implausible data
- Manage travel expenses efficiently according to Fortrea's travel policy
- 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, Case Report Form creation, and clinical trial report writing
- Interact with internal work groups to evaluate needs, resources, and timelines
- Act as contact for clinical trial supplies and vendors
- Perform registry management, feasibility work, and Quality Control visits
- Recruit potential investigators, prepare EC submissions, and negotiate study budgets
- 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 a related allied health profession (e.g., nursing licensure)
- Alternatively, 6 years of recent 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
Preferred Qualifications:
- Local project coordination and/or project management experience
- Ability to maintain confidentiality and demonstrate clinical operations activities
- Strong understanding of medical and clinical research terminology
- Experience using a clinical trial management system (CTMS)
Physical Demands/Work Environment:
- Travel required for site monitoring visits