Clinical Research Coordinator I - Rheumatology

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Day (United States of America)

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A Brief Overview

The Division of Rheumatology at the Children’s Hospital of Philadelphia is dedicated to improving the safety, quality, and health outcomes of children with rheumatic diseases. Ledby Clinical Research Director, Pamela Weiss, MD, MSCE, the Rheumatology Research Core is seeking an experienced Clinical Research Coordinator to work alongside a team of research support staff. This position is full-time. The clinical research coordinator will provide regulatory support for divisional Investigational Drug Application (IND) and Investigational Device Exemption (IDE) studies, day-to-day study management and facilitation of clinical trials, recruitment of patients into clinical research studies, and on-boarding support for team members.

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
• Under the supervision of PI 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, and with HIPAA and management of confidential materials
• Must comply with federal, state, and sponsor policies
• For multi-site studies or collaborations, support communication and meeting scheduling across teams
• Related responsibilities
• Manage essential regulatory documents
• Register study on ClinicalTrials.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
• 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 samples as applicable to the protocol
• Schedule subject visits and procedures
• Retain records/archive documents after study close out

Education Qualifications

• High School Diploma / GED Required
• Bachelor's Degree Preferred

Experience Qualifications

• At least two (2) years of clinical or research related experience Required
• At least three (3) years of clinical or research related experience Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection
• Strong 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:

$53,000.00 - $66,300.00 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.