Clinical Research Coordinator - Rheumatology

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A Brief Overview
Clinical Research Coordinator opening in the Division of Rheumatology for projects related to juvenile arthritis. The Research Coordinator will play a key role in a funded, randomized pragmatic multicenter trial under the direction and guidance of a Principal Investigator and will also be part of a larger Rheumatology research core. The study coordinator will work with 2 other CRCs to coordinate the study activities within the data coordinating center and among all sites. S/he will be responsible for management of the appropriate regulatory and data sharing agreements among all sites and assist other team members in the management of the study data.The Research Coordinator may also work on a variety of projects using a range of methodologies. The ideal candidate will have specialized training in public health or epidemiology, including statistical methods, a thorough understanding of research practices and Institutional Review Board (IRB) procedures, and some clinical trials experience. The candidate should also have an interest in childhood rheumatic diseases. This person will need to exercise discretion and judgment in execution of research protocols, analysis of data, and general project support.

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 clinical related or research related experience Required
• At least three (3) years of clinical or clinical related 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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