POSITION OBJECTIVE: Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Athenex Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with Athenex US and Taiwan Quality Assurance representatives to support compliance and may assist with Athenex site and internal audits as needed.
Essential Job Functions/Responsibilities
- Present training, compliance and performance improvement support to our Clinical Operations team through creative instructional techniques and methods.
- Collaborate with our Clinical Operations leadership team to develop training plans and schedules
- Identify, research and develop training needs, curriculum, tools and materials for delivery on a global platform
- Maintain documentation of training participation
- Develop and monitor training metrics to measure and improve the performance of individuals and teams
- Review and develop Clinical Standard Operating procedures as needed; provide guidance for improvements or updates as needed
- Assess and maintain compliance with FDA and SOP requirements
- Support compliance and internal audits of our US and Taiwan clinical operations teams as needed
- May participate in special assignments as determined by Clinical Operations leadership
Required Education & Qualifications
- Minimum of 5 years of clinical trial experience, with a strong focus on training delivery and development; strong regulatory knowledge is also required
- Bachelor degree in Nursing or life science field
- Experienced in the development and delivery of training materials and tools; strong writing skills required
- Excellent presentation, communication and engagement skills with the ability to communicate in a positive and professional manner
- Collaborative, energetic, team oriented professional who is comfortable with change
- Must be available for up to 20% national or international travel
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.