A BRIEF OVERVIEW

The Leukodystrophy Center at Children’s Hospital of Phila3delphia is seeking several Clinical Research Coordinators (CRCs) to support a large-scale biorepository and natural history study for children and adolescents diagnosed with rare genetic white matter diseases known as leukodystrophies. This work is being led by the Leukodystrophy Center’s clinical research investigators, including Drs. Adeline Vanderver, MD, Amy Waldman, MD, MSCE, Laura Adang, MD, PhD, and Mariko Bennett, MD, PhD, with support from a large team of research associates and scientists, data analysts and biostatisticians, regulatory experts, etc.
Natural history studies seek to identify demographic, genetic, environmental, and other factors that correlate with the development and outcomes of a disease and therefore play an important role in drug development for specific conditions. They are particularly useful in rare diseases, such as leukodystrophies, that exhibit substantial genotypic and/or phenotypic heterogeneity. CRCs work closely with peers and mentors to manage recruitment and enrollment of affected individuals into the study, coordination of research encounters according to a protocol, as well as downstream data collection, management, and analysis. Additional responsibilities include regulatory support, database management, manuscript preparation, and other administrative tasks.
This is a high-volume, fast-paced clinical research environment, and a successful candidate must be able to demonstrate an ability to multi-task proficiently; prior experience working or volunteering in a clinical research environment is strongly preferred. Outstanding written and oral communication skills are essential, as the position involves regular contact with physicians and clinical staff in the Division of Neurology, as well as with patients and their families.
This opportunity is ideal for individuals interested in a career in in the basic or health sciences. CRCs will have opportunities to contribute directly to scientific manuscripts, attend scientific conferences and family symposia, and collaborate with other world-renowned clinician scientists affiliated with the Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN). CRCs will also be eligible to participate in the Pre-Doc Preparatory Program (P3) organized by the ITMAT Education (ITMAT Ed) at the University of Pennsylvania and the Leukodystrophy Center. This is a one-year translational research training program designed to equip early-career clinical research staff who plan pursue further education through medical or graduate school.

EDUCATION QUALIFICATIONS

• High School Diploma / GED - Required
• Bachelor’s Degree - Preferred

EXPERIENCE QUALIFICATIONS

• At least two (2) years of clinical or research related experience - Required
• At least three (3) years of clinical or research related experience - Preferred

SKILLS AND ABILITIES

• 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
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• 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