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Clin Research Coordinator II - Leukodystrophy Center

Philadelphia, PA, US, 19104

Location: LOC_ABRAMSON-Abramson Building 

Req ID: 116664

Shift: Days

Employment Status: Regular - Full Time 

About Us

We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve.

If you are ready to challenge yourself, be inspired and grow – no matter what your role – you just may be the kind of breakthrough maker who will thrive at CHOP.

Job Summary

The Clinical Research Coordinator II (CRC II) will support several disease-specific natural history studies being conducted by the Leukodystrophy Center at Children's Hospital of Philadelphia, a highly specialized program within the Division of Neurology that provides comprehensive clinical care, diagnostic testing, and cutting-edge research for infants, children and adolescents with inherited white matter diseases known as leukodystrophies. 

 

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 data may also be used to identifying and/or developing clinical outcome assessments, validating disease-specific functional/severity scales, identifying and/or developing biomarkers, or even serving as non-concurrent comparator arms in clinical trials. controlled studies.

 

The Leukodystrophy Center is currently conducting natural history studies for several specific leukodystrophies, including Aicardi-Goutières Syndrome (AGS), Pelizaeus-Merzbacher Disease (PMD), and Metachromatic Leukodystrophy (MLD). The CRC II will work closely with the principal investigator, Dr. Adeline Vanderver, MD, as well as other senior project staff to recruit and enroll affected individuals into research studies, and support subsequent data collection, management, and analysis approaches. Additional responsibilities may include regulatory support, database management, and occasional administrative tasks. 

 

This is a high-volume, fast-paced project, 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. The position is ideal for individuals interested in a career in in the basic or health sciences, and a successful applicant must have a demonstrable passion for academic research, as well as a desire to make meaningful contributions to a growing body of knowledge. Outstanding written and oral communication skills are essential, as the position involves regular contact with physicians and clinical staff in the CHOP Leukodystrophy Center, as well as with patients and their families.

 

 

Job Responsibilities

The CRC II will make direct 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 CRC II will also have an opportunity to develop close working relationships with clinicians and researchers throughout the CHOP Division of Neurology, and with collaborators, industry partners, and patient advocacy groups participating in an international research consortium for leukodystrophies.

Job Responsibilities (Continued)

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
  • 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
  • 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 out

 

Also may be responsible for any of the following:

  • 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
  • Document investigational product (drug/device) accountability
  • Self-monitor and self-audit responsibilities
  • Develop informed consent document
  • Maintain Clinical Trial.gov 
  • Develop Case Report Forms
  • Assignments to include more complex studies

Job Responsibilities (Continued)

Required Licenses, Certifications, Registrations

Required Education and Experience

Required Education: Bachelor’s Degree

 

Required Experience: Three (3) years of clinical research coordination experience.

Preferred Education, Experience & Cert/Lic

Preferred Education: Master’s degree in a related field

 

Preferred Experience: Five (5) years of clinical research coordination experience

Additional Technical Requirements

  • Excellent verbal and written communications skills
  • Excellent time management skills
  • Ability to collaborate with stakeholders at all levels

To carry out its mission, it is of critical importance for the Children’s Hospital of Philadelphia (CHOP) to keep our patients, families and workforce safe and healthy and to support the health of our global community. In keeping with this, CHOP has mandated all workforce members on site at any CHOP location for any portion of their time be vaccinated for COVID-19. This mandate also applies to workforce members performing work for CHOP at non-CHOP locations. The CHOP COVID-19 vaccine mandate is in alignment with applicable local, state and federal mandates.

CHOP also requires all workforce members who work in patient care buildings or who provide patient care to receive an annual influenza vaccine. Employees may request exemption consideration for CHOP vaccine requirements for valid religious and medical reasons.

Please note start dates may be delayed until candidates are fully immunized or valid exemption requests are reviewed. In addition, candidates other than those in positions with regularly scheduled hours in New Jersey, must attest to not using tobacco products.

EEO / VEVRAA Federal Contractor

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