Clinical Research Coordinator -Leukodystrophy Center

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A Brief Overview

The Leukodystrophy Center at Children's Hospital of Philadelphia is seeking several Clinical Research Coordinators (CRCs) to support a large-scale biobank 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. Each coordinator works closely with a group of 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-pacedclinical 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, and will include 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), a Rare Diseases Clinical Research Network (RDCRN) consortium funded under grant number U54NS115052 in collaboration between the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Neurological Disorders and Stroke (NINDS).

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

Education Qualifications

• High School Diploma / GED Required
• Bachelor's Degree Preferred

Experience Qualifications

• 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

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

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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