Clinical Research Coordinator II - Advanced Imaging Research - AMPlitude

Children's Hospital of Philadelphia•Philadelphia, PA

1d•Onsite

About The Position

The program in Advanced Imaging Research conducts a wide range of studies related to neuroimaging of brain function and structure in children and adults with neurodevelopmental and/or genetic disorders as well as typically developing individuals. A particular emphasis of our lab is understanding brain mechanisms associated with autism spectrum disorder (ASD). We are seeking a full-time Clinical Research Coordinator (CRC) to assist in the recruitment, screening, and neuroimaging scanning of participants. This individual will collaborate with a multidisciplinary team led by Dr. Tim Roberts. The CRC will lead with minimal supervision all coordination for the AMPlitude research study, an NIH-funded grant that uses multimodal imaging techniques (MRI, MEG, EEG) to explore reliability and stability of brain markers of ASD in adolescents and adults over repeated measurements. The aim of the study is to identify candidate metrics that can show sensitivity to change in future treatment studies. The CRC will have strong interpersonal skills that bolster recruitment and sustain participant engagement across a 4-time-point study participation over a 4- to 6- month time period. The CRC will have regular contact with autistic and neurotypical teens and adults and their families and will work closely with our multidisciplinary team to collect neuroimaging data. The CRC will consent subjects for entry into the required protocol and report to psychologists and investigators on the conduct of the assigned protocol. The CRC will assist in data collection, will manage study documentation and study databases and manage data flow. The CRC will also provide support with Institutional Research Board (IRB) and other research compliance documentation, literature reviews, data analysis, manuscript preparation, and grant and report submissions. Successful applicants will be highly self-motivated, detail-focused, independent problem solvers, and fast learners with strong interpersonal skills who enjoy working in bustling clinical research environments. Prior experience with autism spectrum disorder or other neurodevelopmental/genetic syndromes or behavioral interventions (e.g., Applied Behavior Analysis) is a plus. While most hours are during standard business hours, some occasional evening hours (e.g., once/week) or weekend hours for recruiting events may be needed for this position. This position is primarily on-site, requiring minimum 90% in-person work.

Requirements

Bachelor's Degree Required
At least two (2) years of clinical/research coordination experience Required
Basic knowledge of IRB and human subject protection
Excellent verbal and written communications skills
Strong time management skills
Ability to collaborate with stakeholders at all levels

Nice To Haves

Master's Degree in a related field Preferred
At least three (3) years of clinical/research coordination experience Preferred
Prior experience with autism spectrum disorder or other neurodevelopmental/genetic syndromes or behavioral interventions (e.g., Applied Behavior Analysis) is a plus.

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
Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
Register study on ClinicalTrial.gov as appropriate
Complete case report forms (paper & electronic data capture) and address queries
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 laboratory specimens
Schedule subject visits and procedures
Retain records/archive documents after study close out
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
Organize and/or run study-related meetings locally or across teams (for multi-site projects)
Support study team communications and outreach
Provide training to junior staff on conduct of research studies
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
Maintain Clinical Trial.gov
Develop Case Report Forms
Assignments to include more complex studies