Clinical Research Coordinator I - Advanced Imaging Research, ICON
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 children. A particular emphasis of our lab is understanding causes of autism spectrum disorder (ASD) and co-occurring conditions in order to develop effective treatments. 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 moderate supervision all coordination for the ICON research study, an NIH-funded grant that uses multimodal imaging techniques (MRI, MEG) to evaluate neural mechanisms impacting language development in autistic children with high supports needs, many of whom are non-speaking. Study groups include children with autism and intellectual disability, children with intellectual disability and no autism, children with developmental language disorders (no autism or intellectual disability), and a typically developing comparison group. The CRC will represent the study to the public and have strong interpersonal skills that bolster recruitment and sustain participant engagement. The CRC will have regular contact with neurodevelopmental and neurotypical populations and their families and will work closely with our multidisciplinary team to collect neuroimaging data in children. 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. Prior experience with autism spectrum disorder or other neurodevelopmental/genetic syndromes or behavioral interventions (e.g., Applied Behavior Analysis) is a plus. 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. Previous experience working with neurodevelopmental populations is a plus. Applicants with experience as a Registered Behavior Technician (RBT) are welcomed to apply. 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
- 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 with autism spectrum disorder or other neurodevelopmental/genetic syndromes or behavioral interventions (e.g., Applied Behavior Analysis) is a plus.
- Previous experience working with neurodevelopmental populations is a plus.
- Applicants with experience as a Registered Behavior Technician (RBT) are welcomed to apply.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
