The Children's Hospital of Philadelphia
Philadelphia, PA, USA
Req ID: 24743
Employment Status: AF - Active - Regular - Full Time
The Clinical Research Nurse Coordinator II will work alongside clinical and research staff to support the safe and effective implementation of clinical trials conducted through the CHOP Leukodystrophy Center. The Leukodystrophy Center was founded in 2015 with the mission of providing comprehensive clinical care, advanced diagnostic testing, and cutting-edge therapeutics for infants, children and adolescents with leukodystrophies and other white matter disorders. The Clinical Research Nurse Coordinator II will report directly to the Program Director, Dr. Adeline Vanderver, MD.
This is a high-volume, fast-paced clinical research environment, and a successful candidate must demonstrate the ability to learn new skills effectively and multi-task efficiently. Excellent communication is essential, as the position will involve regular communication with physicians, scientists, research staff, patients, and families. While prior research experience is not strictly required, successful candidates will demonstrate a genuine interest in clinical research, as well as a strong desire to learn about the effective conduct and coordination of clinical trials following federal regulations and Good Clinical Practice (GCP).
The Clinical Research Nurse Coordinator II will make directing and lasting contributions to the development of breakthrough cures and medical treatments in a highly unique patient population affected by rare and complex neurological disorders. The successful applicant will have ample opportunities to build working relationships with clinicians and researchers at CHOP, as well as with collaborators, industry executives, and disease advocates participating in the international Global Leukodystrophy Initiative (GLIA) consortium.
Coordinates research procedures, study visits, and follow-up care per trial protocol(s);
Supports the safety of trial participants by educating families on protocol, study intervention, study drug, etc.
Promptly reports adverse events (AE) and serious adverse events (SAE) to principal investigator, IRB, and study sponsor;
Performs intake of new clinical patients and research subject referred to the CHOP Leukodystrophy Center and determines clinical needs and urgency for visit;
Assists clinicians and study investigators during subject follow-up visits by conducting physical assessments, histories, and review of systems;
Documents clinical and/or research encounters in EMR and develop treatment plans based on patient needs and standards of care;
Complies with Institutional, federal, state, and sponsor policies, standard operating procedures (SOPs) and guidelines;
Works closely with study staff to facilitate pre-study, site qualification, study initiation, monitoring, and close-out visits;
Participates in scholarly activities including research and education;
Participates in professional development activities by maintaining required competencies, identifying learning needs, and seeking appropriate educational offerings.
Expected to Perform all CRC Core responsibilities as detailed for CRNC I:
Applies in depth knowledge of clinical research and coordinates conduct of complex studies..
Manage study finances including sponsor invoicing & resolving study subject billing issues.
Develop advertisement materials, informed consent document, Case Report Forms.
Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals.
Document investigational product (drug/device) accountability.
Self-monitor and self-audit responsibilities.
Facilitate pre-study, site qualification, study initiation, and monitoring visits.
Facilitate study close out activities.
Maintain Clinical Trial.gov /
Assists other team members by educating, providing resources, and consulting on difficult protocols or projects.
Understand good clinical practice (GCP) and regulatory compliance Comply with Institutional, federal, state, and sponsor policies, standard operating procedures (SOPs) and guidelines.
Required Licenses, Certifications, Registrations
RN - Registered Nurse
CPR - Certified Pulmonary Recuscitation
Required Education and Experience
Required Education: BSN
Required Experience: 3+ years nursing/research
Preferred Education, Experience & Cert/Lic
Preferred Licenses/certificates/registrations: ACRP or SOCRA