Clinical Research Coordinator II - Clinical In Vivo Gene Therapy (CIGT)

SHIFT:
Day (United States of America)
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.
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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. Under minimal supervision, the Clinical Research Coordinator II coordinates all clinical research activities within the scope of clinical research protocols within the CIGT. The CRC is responsible for all study activities for multiple clinical trials in various therapeutic areas including hematology, ophthalmology, metabolism, neurology, and audiology. CRCII works closely with PIs and study Sponsors to complete study start-up activities, oversee patient enrollment and ensure all research visits are performed according to protocol. The position also has primary responsibility for IRB submissions and reporting. Must be able to work independently and manage workflow across multiple projects.
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
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
Must comply with federal, state, and sponsor policies
Related responsibilities
Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
Register study on ClinicalTrial.gov as appropriate
Complete case report forms (paper & electronic data capture) and address queries
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 laboratory specimens
Schedule subject visits and procedures
Retain records/archive documents after study close out
Additional Responsibilities may include
Manage study finances including sponsor invoicing & resolving study subject billing issues
Develop advertisement materials
Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
Organize and/or run study-related meetings locally or across teams (for multi-site projects)
Support study team communications and outreach
Provide training to junior staff on conduct of research studies
Document investigational product (drug/device) accountability
Self-monitor and self-audit responsibilities
Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
Maintain Clinical Trial.gov
Develop Case Report Forms
Assignments to include more complex studies
Education Qualifications
Bachelor's Degree Required
Master's Degree in a related field Preferred
Experience Qualifications
At least two (2) years of clinical/research coordination experience Required
At least three (3) years of clinical/research coordination experience Preferred
Skills and Abilities
Basic knowledge of IRB and human subject protection
Excellent 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, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.
EEO / VEVRAA Federal Contractor | Tobacco Statement
SALARY RANGE:
$58,300.00 - $72,900.00 Annually
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.