Clinical Research Coordinator

20 hours ago

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AgelessRx

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Telehealth/Ecommerce start up that provides longevity prescriptions online.

11 - 50

Description

• Manage and coordinate clinical trials in accordance with regulatory requirements and ethical guidelines • Work closely with Clinical Staff, Trial Participants, and Investigators to ensure efficient trial conduct • Liaison between research teams and regulatory bodies to meet clinical research standards • Assist in preparing and submitting IRB applications, amendments, and continuing review reports • Ensure compliance with IRB requirements throughout the clinical study lifecycle • Manage key documents such as study protocols, informed consent forms, and investigator brochures • Maintain a database of reported adverse events and assist in adverse event reports preparation • Conduct regular internal audits to ensure compliance and assist in preparing materials for audits • Provide ongoing support to clinical research staff and ensure effective communication regarding regulatory matters

Requirements

• Bachelor’s Degree in life sciences, healthcare, or related field • A minimum of 2-3 years of experience in clinical research, regulatory affairs, or a similar role, with experience in research involving human subjects • Experience with clinical trial documentation and regulatory submissions • Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB procedures • A passion for diving into health span and lifespan topics and supporting the longevity field's advancement • The ability to take initiative and remain proactive in the quality control of projects, anticipate barriers, and implement mitigation strategies • Ability to approach and educate participants, and effectively communicate details and impacts of a project • Excellent verbal and written communication skills • Excellent organizational and time management skills • Ability to manage multiple tasks and deadlines • Start-up mindset - comfortable leading first-of-its-kind projects and placing value on progress .