Clinical Research Coordinator - Clinical In Vivo Gene Therapy

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Seeking Breakthrough Makers

Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

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 talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children. We strongly encourage candidates of all races, colors, ethnicities, religions, perspectives, sexes, backgrounds, and lived experiences to apply.

A Brief Overview

The Clinical In Vivo Gene Therapy group (CIGT) is dedicated to developing and conducting 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.

What you will do

• Core 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
• Related responsibilities
• 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

Education Qualifications

• High School Diploma / GED - Required
• Bachelor's Degree - Preferred

Experience Qualifications

• At least two (2) years of clinical or research related experience - Required
• At least three (3) years of clinical or research related experience - Preferred

Skills and Abilities

• 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

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, professionals working onsite-at any CHOP location, for any portion of time-must be vaccinated for COVID-19. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.