Clinical Research Coordinator - Cellular Therapy and Transplant Section

Children's Hospital of Philadelphia; Philadelphia (Philadelphia County); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Clinical Research Coordinator II to join their dynamic team. This role is critical in supporting innovative research that directly impacts patient care. You will work in a collaborative environment, coordinating clinical studies and ensuring adherence to protocols. The position offers a unique opportunity to contribute to groundbreaking therapies while being part of a diverse and inclusive workplace. If you are passionate about advancing pediatric care and have a strong background in research coordination, this is the perfect opportunity for you.

Benefits

Health benefits

Mentorship programs

Career growth opportunities

Competitive salary

Qualifications

• Two years of clinical/research coordination experience required.
• Experience with IRB protocols and human subject protection.

Responsibilities

• Coordinate protocol related research procedures and study visits.
• Support the safety of clinical research patients.
• Maintain study source documents and report adverse events.

Skills

Excellent verbal and written communication skills

Strong time management skills

Basic knowledge of IRB and human subject protection

Ability to collaborate with stakeholders

Education

Bachelor's Degree

Master's Degree in a related field

Job description

SHIFT:

Day (United States of America)

Clinical Research Coordinator II

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 CHOP 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 areas.

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 a 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.

Forbes has ranked CHOP the #1 employer in Pennsylvania. Check out this 4-minute video to get a sense of what it's like to work here: https://youtu.be/cvoCGrB6W2w. We are committed to a culture of diversity in all its forms. We offer a competitive salary, health benefits, and other perks. We take mentorship and career growth seriously. BMT is a mission-oriented team that needs and rewards great talent.

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

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