Clinical Research Coordinator II - Center Outcomes REsearch in Surgery; CORES

SHIFT:
Day (United States of America)

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The Center for Outcomes Research in Surgery (CORES) was established in 2023. CORES’s mission is to improve outcomes for children with diseases that require surgical intervention. CORES has created an infrastructure to support a wide breadth of patient‑centered outcomes research (PCOR) in the Department of Surgery, including clinical trials, comparative effectiveness research, implementation science, and qualitative research. PCOR, which transcends clinical specialty, is the embodiment of the tenets for the culture of the DOS at CHOP: starting with the patient, building relationships, and goal‑directed improvement.

The CRC II will assist and support the study teams in the Department of Surgery on their research and/or outcomes improvement projects, with responsibilities including but not limited to participant recruitment, data collection, patient follow up, IRB submission.

• Previous engagement in clinical research and experience with electronic health records and REDCap
• Previous engagement in participant recruitment (screening, consenting, patient follow up, etc.)
• High organizational skills
• Strong communication skills with various types of patients
• Familiarity with IRB protocol submission
• Familiarity with Microsoft Office

• 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 Clinical Trial.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
• Devel…