Clinical Operations Director overseeing patient care in Oncology Clinics at Duke Health. Leading clinical management and strategic planning for Wake County Oncology Clinics.
About the role
- Project Assistant supporting the Clinical Operations department in the organization and execution of clinical studies. Involves collaboration with study centers and training investigators primarily in Germany.
Responsibilities
- Support in organizing the study at investigational sites and in managing investigators
- Query study status at investigational sites (following a predefined guide) and document findings
- Train investigators and site coordinators on the study and on the EDC software
- Conduct feasibility assessments for new projects with investigational sites
- Support the preparation of study documents, including shipping and tracking
- Prepare documents for submission to regulatory authorities and ethics committees
- Create and maintain the Study Master File (SMF)
- Support sites in addressing queries related to electronically captured study data
- Correspondence (using templates or independently, in German and English)
- Shipping and tracking of documents and study materials to investigational sites
- Drafting/editing study contracts (according to templates/guidance)
- Prepare documentation for site remuneration/payment
- Organize investigator meetings
- Prepare presentations, charts and tables (independently and per instruction)
- Provide support to the project support team
Requirements
- Completed vocational training in a medical or commercial/business field
- Ideally, experience in the organization of clinical trials
- Independent and analytical working style
- Good knowledge of the MS Office suite
- Team player with flexibility
- Excellent communication and organizational skills
- Good command of English (written and spoken)
Benefits
- 30 days of vacation based on a 5-day work week
- Flexible working hours
- Overtime compensation (time off or equivalent)
- Option to work up to three days per week from home (60:40 model)
- Company bike (bike leasing)
- Employer savings contributions (VWL)
- Additional pay for health promotion
- Regular company events and team-building activities
- Learning and development opportunities (e.g., Babbel app)
- Free electric vehicle (EV) charging stations
- Fresh fruit basket and unlimited beverages
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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