Perelman School of Medicine University of Pennsylvania
Location
Philadelphia, Pennsylvania
Type
Full time
Description
Job Responsibilities
Adhere to an IRB approved protocol • Participate in the informed consent process of study subjects • Support the safety of clinical research patients/research participants • Coordinate protocol related research procedures, study visits, and follow-up care • Screen, recruit and enroll patients/research participants • Maintain study source documents • Report adverse events • Understand good clinical practice (GCP) and regulatory compliance • Educate subjects and their support members on protocol, study intervention, etc. • Comply with Institutional policies, standard operating procedures (SOPs) and guidelines • Must comply with federal, state, and sponsor policies Related responsibilities • Manage essential regulatory documents • Register and keep study up to date on CRMS • Complete case report forms (paper & electronic data capture) and address queries • Submit documents to regulatory authorities (e.g. IRB, FDA, etc....