- Monitor and manage clinical study sites, including routine monitoring, closeout, pre-study, and initiation visits
- Maintain study files and liaise with vendors
- Ensure study staff receive materials and instructions to safely enroll patients
- Verify informed consent procedures and protocol compliance
- Review source documents and monitor data for missing or implausible information
- Ensure site-level audit readiness and prepare accurate, timely trip reports
- Manage small projects and serve as lead monitor for assigned protocols or projects
- Review project progress and initiate actions to achieve objectives
- Organize and present at Investigator Meetings
- Participate in protocol, Case Report Form, and clinical trial report development
- Coordinate clinical trial supplies and vendors
- Manage registry activities and undertake feasibility work
- Conduct, report, and follow up on Quality Control visits
- Recruit investigators and support ethics committee and regulatory submissions
- Negotiate study budgets and assist with agreements
- Track and follow up on Serious Adverse Event reporting
- Perform CRF review, query generation, and resolution in data management systems
- Train, mentor, and develop current employees
- Coordinate designated clinical projects as a Local Project Coordinator and act as local client contact when assigned
- Perform other duties assigned by management
Requirements
- University or college degree in life science preferred, or certification in a related allied health profession from an appropriately accredited institution
- Nursing certification, medical technology, or laboratory technology qualification accepted
- Minimum 3 years of relevant clinical research experience may substitute for the education requirement
- At least 3 years of clinical monitoring experience
- Thorough knowledge of regulatory requirements, including basic understanding of requirements in other countries
- Thorough understanding of the drug development process
- Fluent in the local office language and English,
written and verbal
- Full understanding of Serious Adverse Event reporting, reports, narratives, and follow-up
- Advanced site monitoring skills
- Advanced study site management skills
- Advanced registry administration skills
- Ability to work with minimal supervision
- Good planning and organization skills
- Good computer skills and working knowledge of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritize workload for self and team
- Ability to work within a project team and effectively in a matrix environment
- Valid driver's license
- Ability to travel, including 60-80% overnight travel
Core Competencies
Demonstrates advanced clinical monitoring and site management skills, with a thorough understanding of regulatory requirements and the drug development process. Proficient in Serious Adverse Event reporting and capable of training and supervising junior staff while managing clinical study sites effectively.