Clinical Research Coordinator II - Advanced Imaging Research

Clinical Research Coordinator

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A Brief Overview

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 coordination for NIH-funded research 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 research 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.

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
• 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
• Related responsibilities
• 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
• Additional Responsibilities may include
• 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

Education Qualifications

• Bachelor's Degree Required
• Master's Degree in a related field Preferred

Experience Qualifications

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

Skills and Abilities

• 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

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 receive an annual influenza vaccine.

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.