Clinical Research Coordinator - Program for Advanced Imaging Research

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Clinical Research Coordinator I

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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

A Brief Overview

The Program in Advanced Imaging Research at the Children's Hospital of Philadelphia is conducting 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 I to assist in the recruitment, screening, and neuroimaging scanning of participants using a novel wearable brainwave scanning technology (wearable "OPM"-MEG). This individual will collaborate with a multidisciplinary team led by Dr. Tim Roberts, a world leader in pediatric MEG. In the initial phase, the role will involve technical setting up the scanning technology and testing it in children and adults, along with integrating video capture data. Once setup is complete, as the CRC, this individual will be relied on to lead with minimal supervision all coordination for the BBQS (brain and behavior quantification and synchronization) research study. The BBQS study is a 4-year, NIH-funded R61/R33 grant using novel imaging (wearable "OPM"-MEG) to evaluate neural mechanisms impacting motor and language development in autistic children with high supports needs, many of whom are non-speaking. Study groups include children with autism+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 consent subjects for entry into the required protocol and report to Psychologists and Principal Investigators on the conduct of the assigned protocol. He/She/They will enter data into study databases, manage data flow, and ensure databases and paperwork are maintained. The CRC will have regular contact with clinical and typically developing populations and their families and will work closely with our multidisciplinary team to collect neuroimaging data in children. The CRC will also provide support with Institutional Research Board (IRB) documentation, literature reviews, data analysis, and manuscript preparation/grant submissions.

Prior experience with autism spectrum disorder or other neurodevelopmental/genetic syndromes or behavioral interventions (e.g., Applied Behavior Analysis) is a plus. Many of the CRC's duties can be learned on the job, although research/clinical experience is appreciated. Successful applicants will be highly self-motivated, detail-focused, independent problem solvers, and fast learners with strong interpersonal skills who enjoy working in bustling research and clinical environments. This position offers valuable clinical research experience in preparation for applying to graduate school or medical school or for advancement to higher level CRC positions within CHOP or elsewhere. As a member of the Radiology department and the Center for Autism Research (CAR), the CRC will have the opportunity to participate in outreach events and attend lectures and seminars on recent findings in autism research, allowing exposure to scientific and clinical leaders in the field of neurodevelopment and brain imaging.

A strong professional with demonstrated efficiency and competent skills mastering in recruitment, research compliance, documentation, and study organization, will be well prepared for advancement to a CRC II/III and future project management responsibilities.

While most hours are during standard business hours, some occasional evening hours (e.g., once/week) may be needed for this position.

What you will do

• 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
• 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
• Related responsibilities
• 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

Education Qualifications

• High School Diploma / GED Required
• Bachelor's Degree Preferred

Experience Qualifications

• At least two (2) years of clinical or clinical related or research related experience Required
• At least three (3) years of clinical or clinical related or research related experience Preferred

Skills and Abilities

• 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

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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