Clinical Research Coordinator - GI

SHIFT:

Clinical Research Coordinator II

Seeking Breakthrough Makers

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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 Position: We are seeking an enthusiastic individual to join the team as a Clinical Research Coordinator. This is a full-time position (100% FTE), with a projected start date between June and July 2025. The candidate for this position will play a critical role in implementing study protocols, recruiting participants, scheduling in-person study visits, and assisting with data management. The candidate will have the opportunity to contribute to the dissemination of study findings, including being an author on abstracts and manuscripts. The candidate is required to have good communication and management skills, with experience doing clinical research. It is desired that the candidate have wet lab experience, and a graduate degree (e.g., MPH, MS). Interested candidates should upload a cover letter and a resume.

Dr. Nik Pai biography: https://www.research.chop.edu/people/nikhil-pai

Pai Lab current projects:

Biomarkers for Assessing Pediatric MASLD:

Cross-sectional observational study aimed at assessing 22 blood-based biomarkers of MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) in children. Study will enroll around 110 patients from CHOP, blood will be collected from patients and processed.

The Role of Soluble Fiber Supplementation in Pediatric Non-Alcoholic Fatty Liver Disease (FIND)

Interventional study assessing whether administered dietary fiber supplements will change the amount of fat deposited in the liver.

NeoGut:

In the works project; building a neonatal biological specimen bank of intestinal tissue. Currently partnering with CHOP's institutional BioBank to store samples of necrotizing enterocolitis for future experimentation.

Intestinal Rehabilitation Program (IRP)Research:

Various research projects aimed at understanding intestinal rehabilitation patients, current projects investigating IRP and allergy, IRP and telehealth. This venture is to empower the IRP program to be a functioning and publishing research arm.

GLP1 Observational Study:

Glucagon-like peptide-1 (GLP1) is a hormone naturally produced in the body that plays a crucial role in regulating blood sugar and appetite. This is an observational study to understand dynamics between MASLD treatment with GLP-1 RA drugs and breath-based biomarkers of MASLD. There is currently a breath 'signature' for MASLD but does that change with treatment of a GLP-1? That is the question.

Various other projects with collaborators:

• University of British Columbia (UBC) precision probiotics project: requires multi institutional and IRB communication

• McMaster University: Dr. Pai's other institution, we work with a number of projects here so securing material transfer agreements (MTAs), data use agreements (DUAs), and communicating with these CRCs is also expected.

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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