Clinical Research Coordinator - Division of Neurosurgery

Children's Hospital of Philadelphia - Philadelphia, PA

Full-time - Entry Level

Philadelphia, PA

10,001+ employees

Hospitals

About the position

The Clinical Research Coordinator in the Division of Neurosurgery at the Children's Hospital of Philadelphia (CHOP) plays a vital role in supporting clinical research activities. This position involves coordinating research protocols, ensuring compliance with regulatory standards, and engaging with patients and families to improve health outcomes for children with congenital anomalies. The role is essential for advancing pediatric care through innovative research initiatives.

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 under the supervision of PI
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
• Manage essential regulatory documents
• Register study on ClinicalTrials.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship samples as applicable to the protocol
• Schedule subject visits and procedures
• Retain records/archive documents after study close out

Requirements

• High School Diploma / GED Required
• Bachelor's Degree Preferred
• At least two (2) years of clinical or clinical related or research related experience Required
• At least three (3) years of clinical or clinical related or research related experience Preferred
• Basic knowledge of IRB and human subject protection
• Strong verbal and written communications skills
• Strong time management skills
• Ability to collaborate with stakeholders at all levels