Clinical Research Coordinator II - Clinical Research Coordinator - Neurofibromatosis and Neuro-Oncology

Children’s Hospital of Philadelphia•Philadelphia, PA

2d•Onsite

About The Position

Children's Hospital of Philadelphia (CHOP) is hiring in Neuro-Oncology, a sub-section of Oncology, under the direction of Dr. Michael Fisher. The Neuro-Oncology team has over 80 ongoing clinical research studies in different phases, covering an array of tumors affecting the central nervous system (CNS). The Principal Investigators (PIs) are dedicated to improving survival outcomes, quality of life, and care for children and young adults with CNS tumors. The PIs are supported by a team of clinical research coordinators, study nurses, nurse practitioners, and other ancillary team members. The group aims to expand its clinical research both within CHOP and collaboratively with institutions across the US and internationally. This role supports a large multi-institutional observational study, functioning autonomously in the clinical research setting. The position is responsible for the management of regulatory, operational, and patient-facing research tasks for specific research projects.

Requirements

Bachelor's Degree Required
At least two (2) years of clinical/research coordination experience Required
Basic knowledge of IRB and human subject protection
Excellent verbal and written communications skills
Strong time management skills
Ability to collaborate with stakeholders at all levels

Nice To Haves

Master's Degree in a related field Preferred
At least three (3) years of clinical/research coordination experience Preferred

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 family on protocol, study intervention, etc.
Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
Comply with federal, state, and sponsor policies
Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
Register study on ClinicalTrial.gov as appropriate
Complete case report forms (paper & electronic data capture) and address queries
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 laboratory specimens
Schedule subject visits and procedures
Retain records/archive documents after study close out
Manage study finances including sponsor invoicing & resolving study subject billing issues
Develop advertisement materials
Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
Organize and/or run study-related meetings locally or across teams (for multi-site projects)
Support study team communications and outreach
Provide training to junior staff on conduct of research studies
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
Maintain Clinical Trial.gov
Develop Case Report Forms
Assignments to include more complex studies