Clinical Research Coordinator II - IMPACT-IRD

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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 does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.

A Brief Overview

The Children's Hospital of Philadelphia Cellular Therapy and Transplant Section (CTTS) is seeking candidates with relevant experience to join our clinical research team! Your work will directly impact our families journey. We offer a unique and exciting multi-disciplinary environment in which to work. Applicants for this position must have demonstrated excellent qualifications, be able to work independently, be flexible and want to work in a team. CTTS treats a variety of diseases utilizing hematopoietic progenitor cells (HPC), genetically modified HPC and immune effector cells (IEC).

Diseases treated include certain types of cancer, disorders of the blood and immune system as well as a wide variety of other rare disorders and syndromes. This position will be responsible for supporting research studies in these key treatment areaswith special focus on diseases that involve immune system dysregulation.

We offer a competitive salary and take mentorship and career growth seriously. We are a mission-oriented team that needs and rewards great talent. The successful candidate will be part of the CTTS multidisciplinary team that implements outstanding cutting edge clinical, translational and outcomes research while providing outstanding clinical care to the patients and families we serve. Areas of research include alternative donor transplants, gene therapy, CAR T cells, and other novel cellular therapies including viral CTLs for treatment of variety viral diseases. Strong communication and organizational skills are necessary for this position as well as the ability to multitask and work in a fast passed often demanding environment.

You can learn more about CTTS at:https://www.chop.edu/centers-programs/cellular-therapy-and-transplant-section.

This position will beMonday-Fridayand the shift will be dependent upon the operational need.

Function independently in a clinical research setting, responsible for the complete coordination of assigned clinical research activities.

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.

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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.