Clinical Research Coordinator

Essential Duties and Responsibilities

• Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
• Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
• Avoid adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
• Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
• Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
• Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
• Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS).
• Address queries and sponsor requests in a timely manner.
• Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
• Aid in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
• Prepare and maintain Essential Documents (The Trial Master File) that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP.
• Coordinating efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
• Foster a patient-care culture that emphasizes patient safety and quality in all aspects.
• Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods.
• Maintains their industry standard licensures and certifications.
• May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
• Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
• Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
• Participate in staff meetings as required.

Qualifications/Requirements

• Bachelor's degree in related field preferred.
• One (1) to three (3) years of experience in clinical research required; nephrology experience preferred.
• Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
• Basic knowledge of kidney care and/or End-Stage Kidney Disease (ESKD) or similar field is a plus.
• Strong verbal and written communication skills required.
• Must have intermediate computer skills, including Microsoft Office (Word, Excel, Outlook and web based tools); proficiency in USRC applications required within 90 days of hire.