Responsibilities
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- Assist with all clinical operations services offered by Flywheel such as data management, user access/training, system administration, help desk services, extensive documentation, reporting, and project management while following Standard Operating Procedures and regulatory guidelines
- Manage system user access and training activities
- Respond to and complete help desk tickets within a timely fashion
- Assist with the development and maintenance of all manuals and documentation relevant to specified duties
- Perform data management and data reconciliation procedures following standard operating procedures as needed
- Maintain accurate project records
- Report and escalate to management as needed
- Assist with risk assessments to minimize project risks
- Establish and maintain relationships with third parties/vendors
- Provide updates and progress reports to clients as needed
- Track project performance, specifically to analyze the successful completion of short and long-term goals
- Position may have access to systems housing Protected Health Information or other sensitive material
- Troubleshoot electronic data capture system errors or user errors using advanced understanding of clinical trial process and biomedical imaging software used to manage the data
- Work closely with other coordinators, software engineers, regulatory affairs and other departments to ensure clients are being provided excellent service and that activities are adhering to the individual contracted scope of work
- Maintain positive and professional client and vendor relationships
- Have exceptional knowledge of biomedical imaging clinical trials
What would make you a great fit
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- A Bachelor’s degree in Science or Computer Science
- GxP Compliance Training
- HIPAA Compliance Training
- 21 CFR Part 11 Compliance Training
- Additional regulatory compliance training as appropriate to clinical trials
- Excellent project management skills
- Excellent written and verbal communications skills
- Excellent organizational and documentation skills
- 3+ years Experience in biomedical informatics, medical imaging, clinical trial operations, and medical research
- 3+ years interacting with professionals in the medical and pharmaceutical industries
- Advanced knowledge of the clinical trial process and terminology
- Certification in project, data management or clinical operations
- Experience managing electronic data systems including system configurations, data management, and user access and training activities
- Experience managing a help desk and responding to tickets in a timely manner
- Excellent analytical and technical troubleshooting skills
- Experience developing and managing system training manuals and documentation relevant to specified duties
- Advanced experience working with Microsoft Office 365
- Keen ability to maintain accurate project records
- Knowledge of the risk management process and ability to assess potential risks and report them to management for review and mitigation
- Provide detail oriented updates and progress reports to clients as needed
- Solid organizational skills including attention to detail and multitasking skills
- Advanced knowledge of computer systems and functionality is a must
