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A Brief Overview
The Division of Rheumatology in close collaboration with the Divisions of Oncology, Immunology, and Gastroenterology have launched a Cellular Therapy Program designed to offer curative approaches to autoimmune and other disorders of immune dysregulation. The focus is on the use of CART-19 therapy for autoimmune diseases such as lupus, dermatomyositis, and scleroderma in children and young adults. This role has a strong emphasis on teamwork and close collaboration with the CAR T cell research team within the Division of Oncology.
• Investigation team includes:
o Dr. Jon M. Burnham (Rheumatology)
o Drs. Caitlin Elgarten and Susan McClory (Oncology)
o Dr. Jennifer Heimall (Immunology)
o Dr. Judith Kelsen (Gastroenterology)
• Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical
research protocols.
• Duties involve managing the day-to-day activities of the research study under the guidance of PI, coordinating
multidisciplinary study visits, data collection, data management, regulatory oversight, adverse event reporting, and sponsor communication.
• Skills required include study management, strong communication skills, problem solving, and patient/family communication.
This is an extremely exciting time as the field of cellular therapies for autoimmunity is in its infancy - we anticipate lots of growth!
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:
$56,890.00 - $71,110.00 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.