SHIFT:
Day (United States of America)
The Division of Rheumatology at the Children’s Hospital of Philadelphia is dedicated to improving the safety, quality, and health outcomes of children with rheumatic diseases. Led by Clinical Research Director, Pamela Weiss, MD, MSCE, the Rheumatology Research Core is seeking an experienced Clinical Research Coordinator to work alongside a team of research support staff. This position is full-time. The clinical research coordinator will provide regulatory support for divisional Investigational Drug Application (IND) and Investigational Device Exemption (IDE) studies, day-to-day study management and facilitation of clinical trials, recruitment of patients into clinical research studies, and on-boarding support for team members.
Responsibilities:
1. Adhere to an IRB approved protocol
2. Participate in the informed consent process of study subjects
3. Support the safety of clinical research patients/research participants
4. Coordinate protocol related research procedures, study visits, and follow-up care
5. Screen, recruit and enroll patients/research participants
6. Maintain study source documents
7. Under the supervision of PI Report adverse events
8. Understand good clinical practice (GCP) and regulatory compliance
9. Educate subjects and family on protocol, study intervention, etc.
10. Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
11. Must comply with federal, state, and sponsor policies
12. For multi-site studies or collaborations, support communication and meeting scheduling across teams
13. Assist divisional investigators with the development, application, management, and close-out processes of IND & IDE studies by helping with FDA submissions and regulatory oversight
Related Responsibilities
1. Manage essential regulatory documents
2. Register study on ClinicalTrials.gov as appropriate
3. Complete case report forms (paper & electronic data capture) and address queries
4. Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (i.e., DSMB, independent safety officer)
5. Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
6. Facilitate study close out activities as appropriate
7. Coordinate research/project team meetings
SKILLS AND ABILITIES:
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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.
A Brief Overview
Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols.
What you will do
Education Qualifications
Experience Qualifications
Skills and Abilities
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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.
Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.
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