Clinical Research Assistant II-Clinical In Vivo Gene Therapy (CIGT)
About The Position
The Clinical In Vivo Gene Therapy group (CIGT) is dedicated to developing and conducting adeno-associated virus gene transfer and molecular therapy trials at Children’s Hospital of Philadelphia. Through industry partnerships and investigator-initiated trials, CIGT seeks to further the development of transformative human therapies and to build upon CHOP’s legacy as a leader in gene therapy research. Led by experts in in vivo gene therapy research, with more than 10 years of clinical trial experience, the CIGT team has a wealth of knowledge to navigate the complex safety, regulatory, and clinical care considerations of gene therapy clinical research. Our group offers resources to support the startup and conduct of industry-sponsored trials, as well as regulatory and clinical operations support for CHOP investigator-initiated clinical trials. The CRA II is responsible for assisting with daily clinical research operations, including informed consent, data entry, and participant visits.
Requirements
- High School Diploma / GED Required
- At least one (1) year of relevant clinical research experience Required
- Basic knowledge of IRB and human subject protection.
Nice To Haves
- Bachelor's Degree Preferred
- At least two (2) years of relevant clinical research experience Preferred
Responsibilities
- Providing technical and clinical support in the conduct of clinical studies:
- Filing and office organization
- Patient/research participant scheduling
- Patient/research participant history
- Data collection/extraction from electronic medical record systems and entry into project databases and platforms
- Data management, including assisting with quality control and data review
- Laboratory procedures
- Research Study Compliance
- Adhere to IRB approved protocols and compliance with HIPAA and handling confidential materials
- Support the safety of clinical research patients/research participants
- Comply with Institutional policies, SOPs and guidelines
- Comply with federal, state, and sponsor policies
- Participate in the informed consent process for study subjects
- Document and report adverse events
- Maintain study source documents
- Submit basic IRB reports
- Assist with IRB/regulatory submissions
- Complete case report forms (paper and electronic data capture)
- Follow-up care
- Order materials/supplies
- Schedule research meetings
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
