Job Description Req ID: 18450
Employment Status: AF - Active - Regular - Full Time
The Center for Autism Research (CAR) is conducting a wide range of studies seeking to identify the causes of autism spectrum disorder (ASD), and to explore effective interventions and other supports for families throughout the region who are affected by ASD. Working at CAR provides the opportunity to be a part of innovative, break-through research on a complex developmental disorder that affects 1 in 68 people in the United States. Most studies at CAR involve behavioral evaluations, brain imaging, interventions, and/or genetics, and are aimed at explaining the underlying mechanisms of this complex disorder.
The Clinical Research Regulatory Specialist assumes a central, key supportive role for all studies conducted under the auspices of the Center for Autism Research (CAR). This position is responsible to assist with the writing, review, and submission of all study protocols, amendments, informed consent documents, annual reviews and safety reports to the CHOP IRB. This position will also serve as a central resource for all CAR staff for all human subjects regulatory matters and may provide training and support to CAR staff to ensure compliance with study protocols, federal regulations, and CHOP, CHOP IRB, NIH, and FDA policies.
Write protocols, informed consent forms, and other study documents for submission to the IRB
Amend studies and update study staff list as necessary
Submit continuing reviews and study updates to the IRB as required
Maintain approved IRB documents for all studies
Monitor active and non-active studies to ensure that studies are in compliance regarding enrollment numbers, consent documentation, study staff training, etc.
With CAR’s Data and Statistics Core, ensure that studies are collecting and storing data according to the study protocol and applicable policies
Serve as the liaison between CAR and other groups within the Research Institute (e.g. IRB, CHPS, PeRC, COI, REC)
Provide support, guidance, and training for research staff in matters of human subjects protection and compliance
Provide guidance in the development, implementation, and evaluation of the conduct of clinical research
Work collaboratively and effectively with individual study teams, collaborators, and other institutions
Keep abreast of changes to CHOP policies (including IRB policies) as well as federal regulations
Attend trainings offered by the IRB, Office of Research Compliance, or other organization, either in-person or online