Clinical Research Project Coordinator, Translational Science Unit (Hybrid)
About The Position
Responsibilities include overseeing study and regulatory operations including startup, maintenance and closeout for multiple multi-center, international clinical research studies, protocol compliance, regulatory documentation, quality control, data monitoring and reporting, Institutional Review Board (IRB) submissions, coordination of invoicing with administration and supervision of coordinator activities. Provides support and database maintenance for ongoing research programs in database reviews and developing reports and tables documenting study status. Manage and summarize study activities and data exports both internally for invoicing purposes and externally. Maintain Standard Operating Procedures including SOP development, maintenance, tracking and implementation. Oversee production and submission of invoicing backup documents to department administration for approval and invoice generation. Maintain study-specific invoicing records. Additional Responsibilities Performs other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Requirements
- 3+ years of experience coordinating multiple projects and or process improvements (Required)
- Effective oral and writing communication skills are. (Required proficiency)
- Must have the capability to work independently once objectives and requirements have been established. (Required proficiency)
- Excellent computer skills and ability to use multiple software programs, including database programs, are. (Required proficiency)
Nice To Haves
- Bachelor's Degree in Business, Healthcare Administration or related field (Preferred)
- Experience with clinical research, clinical trials and/or familiarity with the academic medical setting (Preferred)
- Project management experience or experience managing multiple priorities, Strong Excel skills (Preferred)
Responsibilities
- overseeing study and regulatory operations including startup, maintenance and closeout for multiple multi-center, international clinical research studies
- protocol compliance
- regulatory documentation
- quality control
- data monitoring and reporting
- Institutional Review Board (IRB) submissions
- coordination of invoicing with administration
- supervision of coordinator activities
- Provides support and database maintenance for ongoing research programs in database reviews and developing reports and tables documenting study status
- Manage and summarize study activities and data exports both internally for invoicing purposes and externally
- Maintain Standard Operating Procedures including SOP development, maintenance, tracking and implementation
- Oversee production and submission of invoicing backup documents to department administration for approval and invoice generation
- Maintain study-specific invoicing records
- Performs other duties as assigned
- Complies with all policies and standards
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
