Clinical Research Coordinator II - Hill Lab

Children's Hospital of Philadelphia; Philadelphia (Philadelphia County); On-site; USD 58,000 - 73,000; Full time

Job summary

The Hill Research Lab at Children's Hospital of Philadelphia (CHOP) Division of Allergy and Immunology is seeking a Clinical Research Coordinator II to support human studies focused on atopic diseases and irritable bowel syndrome, under minimal supervision.

The CRC II will screen, consent, and enroll subjects, transport samples, and manage regulatory documents, while ensuring compliance with GCP, IRB, and sponsor requirements, collaborating with the PI and study staff to advance pediatric

Qualifications

• IRB knowledge and human subject protection.
• Excellent verbal and written communications skills.
• Strong time management skills.
• Ability to collaborate with stakeholders at all levels.

Responsibilities

• Adhere to an IRB approved protocol.
• Participate in the informed consent process of study subjects.
• 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 and study interventions.
• Prepare, manage, submit, and maintain essential regulatory documents and monitor regulatory status.

Skills

IRB knowledge

Verbal & written communication

Time management

Stakeholders collaboration

Education

Bachelor's degree

Master's degree

Job description

SHIFT:

Day (United States of America)

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

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 or managing study staff.

The Hill Research Lab in the Division of Allergy and Immunology is seeking a Clinical Research Coordinator II with excellent communication skills and a warm disposition to assist in recruitment of research subjects to their human studies, which center on atopic diseases (ie. eosinophilic esophagitis, asthma, IgE food allergies) and irritable bowel syndrome. The CRC II will screen, consent, and enroll research subjects on applicable IRB protocols and transport blood samples from the endoscopy suite, CHPS, or occasionally satellite locations to the Hill lab, the clinical immunology lab, and/or the BioRC SPTU lab. Occasionally, the CRC II will transport tissue samples from the operating room to the Hill lab. The CRC II will function independently in their role and is

committed to a career in research.

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:

$58,300.00 - $72,900.00 Annually

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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.