Job Description
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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.
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 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 of clinical/research coordination experience Preferred
Skills and Abilities
- 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
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. EEO / VEVRAA Federal Contractor | Tobacco Statement
SALARY RANGE: $56,890.00 - $71,110.00 Annually
Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.
At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.
Job Tags
Full time, Part time, For contractors, Shift work,