Clinical Research Coordinator II - Radiology, Brains Change

Children’s Hospital of Philadelphia • Philadelphia, PA

2d

About The Position

The Brains Change team conducts a wide range of neuroimaging studies related to brain function and structure in typically developing infants as well as preschool children born premature. We are seeking to understand brain development from birth to early childhood. Recruited participants include infants, toddlers, and preschool children.
We are seeking a full-time Clinical Research Coordinator (CRC) to help manage our infant and preschool children brain imaging studies. This individual will work closely with the team of principal investigators, psychologists, post docs, research coordinators and research assistants and imaging techs. The CRC will help recruit study participants for brain imaging visits, creating and maintaining study regulatory binder and REDCap databases, prepare and update study IRB paperwork, subject management including supporting children and families through their research study participation (oversee informed consent, screening, compensation, and billing). The CRC will have regular contact with typically developing and neurodivergent populations and their families.
Prior experience with some or all of these duties (especially prior experience managing a REDCap database, IRB, and study regulatory binders) is a plus; as are excellent problem identification and problem solving skills for the team. Successful applicants will be highly self-motivated and fast learners who enjoy working in a bustling clinical research environment.

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 some or all of these duties (especially prior experience managing a REDCap database, IRB, and study regulatory binders) is a plus; as are excellent problem identification and problem solving skills for the team.
• Successful applicants will be highly self-motivated and fast learners who enjoy working in a bustling clinical research environment.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level