Clinical Research Coordinator I - Nephrology

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
• Care for coordination of 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, 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

• A High School Diploma / GED - Required
• A 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