Clinical Research Assistant II - Clinical In Vivo Gene Therapy

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.

With supervision, the Clinical Research Assistant II may participate in the following research activities: subject recruitment, confirmation of subject eligibility, chart abstraction, informed consent process, subject scheduling, completion of case report forms, data entry/clarification, IRB preparations, adverse event and serious adverse event recording and reporting, management of regulatory documents, and shipment of laboratory specimens.

CHOP's Commitment to Diversity, Equity, and Inclusion
CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

Responsibilities

• Assist in participant scheduling, history intake, and follow-up care.

• Collect, enter, and manage data.

• Adhere to IRB-approved protocols, laboratory procedures, and institutional, federal, state, and sponsor policies.

• Complete administrative duties, including filing, organizing, ordering supplies, and scheduling meetings.

• Participate in the informed consent process for study subjects.

• Document and report adverse events.

• Maintain study source documents, submit IRB reports, and complete case report forms.

Education

• Required: Associate degree

• Preferred: Bachelor's degree

Experience

• Required: At least two (2) years relevant clinical research experience

• Preferred: Experience with IRB, participant recruitment, informed consent, and/or eligibility screening

Skills and Abilities

• Basic knowledge of IRB and human subject protection