Clinical Research Coordinator I - Brain Gene Development Lab

SHIFT:

Day (United States of America)

Seeking Breakthrough Makers

Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career.

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A Brief Overview

At the Brain-Gene Development Lab, we use brain MRI to investigate normative human brain development, as well as the altered developmental trajectories associated with neurocognitive and psychosocial vulnerabilities. We are seeking a mission-driven individual who is prepared for a preferred 3-year work commitment to join our team as a Clinical Research Coordinator. This is a hybrid position (preferably 3 days in-person) with standard working hours; we do not expect any very early or late evening study visits.

As of right now, our study is conducted entirely remotely, meaning all patient contact is done through phone calls and emails. This may change as we incorporate prospective neuroimaging in the future. While a background in psychology is preferred, no prior experience in brain imaging, statistics, or data analysis is required. If you are enthusiastic and motivated to work in a clinical research setting, we encourage you to apply!

• 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 research related experience Required
• At least three (3) years of clinical 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 receive an annual influenza vaccine. Learn more.

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