Manage day-to-day operations of multiple research projects. Recruit, screen, and enroll potential study subjects as specified per protocol. Conduct study visits and collect specimens. Monitor and track subjects. Collect, review, and report timely, valid, accurate study data for studies with patients in long-term survival follow up. Oversee cataloguing and distribution of biological samples.
Develop and implement study protocol designs, construction of source documents, databases, and case report forms. Maintain databases and study documentation.
Prepare and submit Institutional Review Board (IRB) documentation including submissions, continuing reviews and amendments. Prepare and submit documentation to other regulatory bodies such as the Abramson Cancer Center.
Coordinate and facilitate study related meetings and communications. Create data reports and meeting presentation materials to present at weekly or recurring meetings with team leadership and team members. Review the status of studies including accrual, data entry, queries, deviations, and identification and resolution of subject issues.
Assist with data cleaning and quality control for large volume interim analysis.
Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.