Clinical Research Coordinator I (Leukodystrophy Center)

Children’s Hospital of Philadelphia•Philadelphia, PA

12h

About The Position

The Leukodystrophy Center at Children's Hospital of Philadelphia is seeking one or more Clinical Research Coordinators (CRCs) to support a large biorepository and natural history studies for children, adolescents, and adults diagnosed with a group of rare genetic neurological disorders 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, Giulia Porcari, MD, and Mariko Bennett, MD, PhD, with support from a 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 CRC 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. The Leukodystrophy Center’s research program is high-volume and fast-paced, and a successful candidate must be able to demonstrate an ability to multi-task with little to no errors. Prior experience in a laboratory setting is preferred. Outstanding written and oral communication skills are essential, as the position involves regular contact with collaborators within and externally to the Children’s Hospital of Philadelphia. The Leukodystrophy Center is a founding member of the Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN), a Rare Diseases Clinical Research Network (RDCRN) consortium funded under grant number U54NS115052 as a collaboration between the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Neurological Disorders and Stroke (NINDS).

Requirements

High School Diploma / GED - Required
At least two (2) years of clinical or research related experience - Required
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

Nice To Haves

Bachelor's Degree - Preferred
At least three (3) years of clinical or research related experience - Preferred
Prior experience in a laboratory setting is preferred.

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
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