Clinical Research Coordinator I - Nephrology

Children’s Hospital of Philadelphia • Philadelphia, PA

1d

About The Position

The Division of Nephrology at the Children’s Hospital of Philadelphia conducts many research studies to understand kidney disease, advance current treatments, improve quality of life, and develop new therapies. We are seeking an enthusiastic individual to join our research team as a Clinical Research Coordinator. The coordinator will primarily work on the IMPAKT study, Imaging Modalities in Pediatric Assessment of Kidney Transplants, led by Dr. Bernarda Viteri. In this study, we are developing new magnetic resonance imaging (MRI) and ultrasound methods to determine if it is effective in diagnosing complication in kidney transplant patients. The project is funded by the National Institutes of Health. 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. An ideal candidate is highly organized, diligent, has strong communication and management skills, empathetic to patients and families, and has experience working in clinical research. The candidate may also assist with other ongoing projects in the Division or with new projects that are initiated after their start date.

Requirements

• High School Diploma / GED - Required
• At least two (2) years of clinical or research related experience - Required
• 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

Nice To Haves

• Bachelor's Degree - Preferred
• At least three (3) years of clinical or research related experience - Preferred

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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED