Clinical Research Coordinator I - Rheumatology
About The Position
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.
Requirements
- High School Diploma / GED Required
- At least two (2) years of clinical or research related experience Required
- Basic knowledge of IRB and human subject protection
- Strong verbal and written communications skills
- Strong time management skills
- Ability to collaborate with stakeholders at all levels
Nice To Haves
- Bachelor's Degree Preferred
- At least three (3) years of clinical or research related experience Preferred
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
- Under the supervision of PI 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, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- Complete case report forms (paper & electronic data capture) and address queries
- Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie, DSMB, independent safety officer)
- 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 samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Benefits
- annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
