Clinical Research Coordinator I - (Leukodystrophy Center)

Company: Children's Hospital of Philadelphia
Location: Philadelphia
Posted on: March 19, 2023

Job Description:

SHIFT:Day (United States of America)Seeking Breakthrough Makers

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At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

A Brief Overview
The Leukodystrophy Center at Children's Hospital of Philadelphia is seeking a Clinical Research Coordinator (CRC) to support one or more natural history studies for children and adolescents diagnosed with rare genetic white matter diseases known as leukodystrophies. This work is being led by the Leukodystrophy Center's Program Director/Principal Investigator, Dr. Adeline Vanderver, MD, in collaborator with senior research associates, data management experts, biostatisticians, 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. The CRC will work closely with a group of peers and mentors to independently 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 may 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, 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
• Report adverse events
• Understandgood 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
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Manage essential regulatory documents
• Register study on ClinicalTrial.gov
• 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
• Facilitate study close out activities
• Coordinate research/project team meetings
• Collect, process and ship laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close outEducation Qualifications
  • Associate's Degree Required
  • Bachelor's Degree PreferredExperience Qualifications
    • At least three (3) years of coordination related, clinical related or research related experience. RequiredSkills and Abilities
      • Excellent verbal and written communications skills
      • Excellent 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, professionals working onsite-at any CHOP location, for any portion of time-must be vaccinated for COVID-19. Learn more.
        
        CHOP also requires employees who work in patient care buildings to receive an annual influenza vaccine. 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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Keywords: Children's Hospital of Philadelphia, Philadelphia , Clinical Research Coordinator I - (Leukodystrophy Center), Healthcare , Philadelphia, Pennsylvania