Clinical Research Coordinator - Late Effects Of Childhood Cancer Therapy

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

This position is seeking a Clinical Research Coordinator (CRC) for clinical research in Late Effects of Childhood Cancer Therapy conducted within the CHOP healthcare network. The Principal Investigator (PI) is a double-boarded physician in Pediatric Oncology & Pediatric Endocrinology with a NIH-funded research program focused on addressing endocrine late effects in childhood cancer survivors.

The ideal candidate would be interested in research related activities such as confirmation of subject eligibility, recruitment, enrollment and informed consent of study subjects; preparation of study packets, study visit scheduling, accompanying research subjects for their clinical research visits; completion of study case report forms; data clarification, collection, abstraction, storage and entry; serving as PI liaison with other research groups; participation in grant related meeting with PI to gain better understanding of protocol issues and development; responsible for meeting enrollment projections within study-specified time lines; IRB submissions, amendments, and continuing reviews; oversight of regulatory requirements, preparation of research reports and manuscripts; data analysis under PI guidance; assistance with preparing research grants, literature reviews and article retrieval; maintenance of endnote or related literature libraries; completion of CITI training if selected for the position.

This position provides great research opportunity, mentorship by PI, and valuable experience for candidates with a strong interest in pursuing a future professional position within the healthcare-related field (medical school or graduate school). The PI has multiple funded grants providing an exciting and terrific opportunity to conduct high quality clinical research in a supportive and collegiate work environment.

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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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.