Coordinating trial related activities ensuring adherence to protocols and regulatory compliance
Maintaining regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards
Preparing and participating in study monitoring and audit visits
Communicating with potential patients, pre-screening, scheduling, consenting, and enrolling patients
Ensuring all enrolled subjects have a documented eligibility checklist and signed consent
Coordinating research visits and maintaining source documentation
Performing data collection and completing CRFs
Handling and processing biospecimens when applicable
Tracking AE/SAE and maintaining study logs
Conducting follow-up phone calls to participants
Uploading data to relevant databases and performing data QC
Documenting all trainings and essential correspondence related to the study
Attending study-related meetings and maintaining/ordering study materials
Promoting good clinical practice in the conduct of clinical investigations

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience
Regulatory experience is preferred
Radiation Oncology experience is preferred but not required
Effective problem-solving abilities
Effective communication and writing skills
Strong organizational and time management skills
Flexible and able to multi-task
Strong attention to detail
Ability to work as part of a team as well as independently
Knowledge of IRB and human research protection regulations
Demonstrates high reliability and a good work ethic.

Health, Life, and Flexible Spending Accounts
Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
Flexible spending accounts for eligible health care and dependent care expenses
Exceptional tuition benefits for employees, spouses, and dependent children
Generous retirement plans (Basic, Matching, and Supplemental)
Substantial time away from work during the year
Long-Term Care Insurance
Wellness and Work-life Resources
Professional and Personal Development resources
Access to a wide range of University resources, cultural and recreational activities
Discounts and Special Services for University faculty and staff
Flexible work options

Clinical Research Coordinator A/B

Key skills