Clinical Research Coordinator - Center for Fetal Diagnosis and Treatment - MOMS

SHIFT:

Day (United States of America)

Clinical Research Coordinator II

Seeking Breakthrough Makers

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A Brief Overview

This position will work with the Center for Fetal Diagnosis and Treatment team  following up on patients enrolled in  the landmark MOMS (Management of Myelomeningocele Study)  and will be a critical part of coordinating several sentinel studies focusing on Maternal and Fetal Health following the diagnosis of a Birth Defect. Diagnoses include twin pregnancies,  surgical birth defects, and fetal spina bifida. The team is a dynamic part of the Center, and includes several national multicenter trials. Here is the link to the CFDT website:

https://www.chop.edu/centers-programs/center-fetal-diagnosis-and-treatment

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 o