Clinical Research Coordinator I - Neuro-Oncology
Children’s Hospital of Philadelphia
- Philadelphia, PA
- Permanent
- Full-time
Children's Hospital of Philadelphia is hiring in Neuro-Oncology, a sub-section of Oncology. The Neuro-Oncology team is under the direction of Dr. Michael Fisher, who also serves as the Director of the Neurofibromatosis Clinical Trials Consortium (NFCTC). We currently have over 80 ongoing clinical research studies, in different phases, that cover an array of tumors that affect the central nervous system (CNS). Our Principal Investigators (Pl) are dedicated to improve the survival outcomes, quality of life, and care of children and young adults with CNS tumors. The PIs are joined with a team of clinical research coordinators, study nurses, nurse practitioners, and other ancillary team members. Our group aims to grow our clinical research further, both within the Children's Hospital of Philadelphia, but also collaboratively with institutions through the US and internationally. We are hiring to support a new multi-institutional outcomes study.What you will do
- Core 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
- Under the supervision of PI Report adverse events
- 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
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Related responsibilities
- 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
- 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