Clinical Research Assistant II- The Clinical In Vivo Gene Therapy Group

SHIFT: Day (United States of America) Seeking Breakthrough Makers

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• A Brief Overview 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.

Under the direct supervision of the Principal Investigator and/or other study team members, this role provides experienced support in the conduct of clinical research.

Job responsibilities may include human subject research activities including but not limited to subject enrollment, data/sample collection, data entry, and regulatory submissions support.

What you will do 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 Additional Responsibilities may include: 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 Education Qualifications High School Diploma / GED Required Bachelor's Degree Preferred Experience Qualifications At least one (1) year of relevant clinical research experience Required At least two (2) years of relevant clinical research experience Preferred Skills and Abilities Basic knowledge of IRB and human subject protection.