Position Summary: The Clinical Trial Coordinator (CTC) is responsible for providing administrative and operational support for the day-to-day execution of clinical trials. The CTC will conduct routine duties associated with study device and supply management, payments, document tracking and filing, as well as assisting with the activities of the study team and associated vendors.
- Support clinical study team(s) as an expert in document management
- Collect, review and file essential clinical trial documents; identify and track issues to resolution
- Prepare, manage and archive clinical study documentation in accordance with applicable regulations
- Conduct quality checks of clinical study documentation/files
- Prepare investigational device shipments, maintain stock levels and manage tracking and reconciliation of study devices
- Assist with financial accruals, site and vendor payments, and maintenance of associated payment systems
- Create and maintain internal study-specific tools (e.g., site lists, contact information)
- Manage the generation, translation, assembly and distribution of study materials
- Serve as primary liaison with document translation vendor(s)
- Assist with the planning, management and execution of clinical meetings (including internal meetings, investigator meetings and other trial related meetings)
- Support clinical trial sites directly/indirectly through assigned study managers, as needed
- Generate and disseminate clinical trial correspondence including newsletters, global correspondence, etc.
- Handle confidential and proprietary information in accordance with applicable laws and regulations
- Ensure optimal communication with internal and external partners specific to administrative tasks of the team
- Proactively identify and resolve operational project issues and participate in process improvement initiatives as required
- Provide general logistical support for clinical trials, such as creating agendas and taking minutes at meetings, and assisting with purchasing and/or budget activities
- High School Diploma or technical certification
- At least 2 years supporting clinical trials in an administrative capacity
- Excellent computer skills including proficiency in Microsoft office
- Self-motivated, detailed oriented, and capable of working independently
- Strong organization and time management skills; ability to work on multiple projects simultaneously
- Excellent critical thinking and communication skills
- Bachelor’s Degree in science or medical related field
- Working knowledge of Good Clinical Practice and FDA regulations
Physical Job Requirements:
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.