About this role
Role Overview
- Identifies and verifies appropriate clinical source documentation for data reporting
- Coordinates data collection with the clinical research team to facilitate efficient and accurate data reporting and regulatory documentation
- Gathers and extracts patient clinical data for entry into later phase industry and federal sponsor-supplied case report forms
- Ensures timely and accurate completion of case report for review by study sponsor and perform data integrity reviews
- Maintains individual research subject records by obtaining copies of medical records, lab reports, treatment schedules, and other vital protocol-related information
- Updates clinical records for review while subjects remain on study
- Manages backup and data archives
- Assists in the regulatory aspects of protocol, including regulatory document preparation, IRB application preparation, adverse event reporting, and IRB communications
- Maintains knowledge of professional principles, legal and/or reporting requirements affecting clinical data research and management
Requirements
- Master’s degree in allied healthcare, biology, computer science, or related field
- A minimum of 0-6 months of experience in managing and/or coordinating data, data collection and/or reporting in a research or clinical setting
- Any equivalent combination of related education and/or experience will be considered
- Preferred to have research certification such as CCRP, CCRA, CCDM, etc. from accredited organizations such as SOCRA, ACRP and SCDM
Benefits
- 37.5-hour work week
- 13 paid holidays
- 24 annual leave days per year
- 18 sick days per year
- WVU offers a range of health insurance and other benefits
- 401(a) retirement savings with 6% employee contribution match
- Wellness programs