Perform a variety of administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies.
Essential Functions
Provide clinical research support to investigators and site staff, including verifying and/or correcting research study information on source documents, resolving research queries and variances, and providing feedback to the site data collector.
Input research study data into the trial Electronic Data Capture (EDC) system, maintaining quality control for content, accuracy, and completeness.
Prepare and maintain research study files; compile, collate, and submit study information within established deadlines.
Collect and submit regulatory/ethics documentation pertaining to the research study.
Maintain the FDA 1572 form for assigned research studies.