Clinical Research Coordinator - Comprehensive Vascular Anomalies Program CVAP

SHIFT:

Day (United States of America)

Clinical Research Coordinator II

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.

CHOP’s Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage candidates of all races, colors, ethnicities, religions, perspectives, sexes, backgrounds, and lived experiences to apply.

A Brief Overview
The Comprehensive Vascular Anomalies Program (CVAP) is an interdisciplinary group of physicians, support staff and administrative staff who together collaborate to improve the outcomes for patients with vascular anomalies (VA). VAs encompass a diverse group of diagnoses including tumors and malformations. Recently, significant research in the molecular causes of these disorders has expanded therapeutic treatment options and other innovative diagnostic techniques for disease assessment and drug delivery.

The program is composed of experts in the field of VAs including surgeons (plastic, orthopedic, ENT, neurosurgery, urology, fetal, and general surgery), dermatology, hematology, oncology, genetics, radiology (interventional, diagnostic), ophthalmology, pulmonary, endocrinology, gastroenterology and infectious disease. Every specialist has a role in treating vascular anomaly patients. Support staff includes APPs, RNs, administrative staff, PT, OT, social work and psychology.

Our CVAP program has pioneered discovery in the genomics of VAs. Our goal is to establish CHOP CVAP as a premier interdisciplinary program in VAs. We will do this by establishing a world-class clinical, translational and basic science program to improve outcomes of patients of all ages with VAs.

The CVAP Program is linked to the Center for Applied Genomics (CAG) and the CVAP portfolio already includes national registries, industry sponsored protocols, investigator-initiated protocols, a managed access protocol, and single INDs.

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