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