About the role
AgelessRx's Clinical Research Coordinator will play a pivotal role in the Applied Science vertical by managing and coordinating clinical trials in accordance with regulatory requirements and ethical guidelines. As Clinical Research Coordinator, you will work closely with Clinical Staff, Trial Participants, and Investigators in order to ensure an efficient and smooth conduct of AgelessRx trials from the planning phase through trial completion. Additionally, the Clinical Research Coordinator will be the liaison between research teams and regulatory bodies to ensure that studies meet the highest standards of clinical research.
The ideal candidate will possess a strong knowledge of good clinical practices, FDA regulations, and IRB process, and enthusiasm for exploring the longevity space, active involvement in project quality control, and clinical research experience with an emphasis on clinical trial documentation and regulatory submission.
What you'll do
Institutional Review Board (IRB) Management:
Assist in preparing and submitting IRB applications, amendments, and continuing review reports and ensure that forms and responses to inquiries are submitted promptly and accurately
Ensure compliance with IRB requirements throughout the clinical study lifecycle by tracking approvals, renewals, and expiration dates
Regulatory Documentation:
Ensure that the trial binder (e.g., Investigator Site File) is kept up-to-date and complete, and oversee the archiving and retrieval of trial documents in accordance with GCP guidelines
Manage key documents such as study protocols, informed consent forms, investigator brochures, as well as ensuring regulatory approvals and amendments are properly documented
Adverse Event Reporting:
Maintain a database of reported adverse events and assist in the preparation and submission of adverse event reports to the IRB and other regulatory bodies as required
Contribute to the assessment and classification of adverse events in collaboration with the Applied Science team to ensure that all adverse events are accurately documented and reported
Study Monitoring and Compliance:
Prepare study monitoring plans, conduct regular internal audits to ensure compliance, and assist in preparing materials for sponsor audits and inspections
Provide support to clinical research coordinators and investigators in meeting regulatory requirements and contribute to the development of research protocols, including background, objectives, and study design
Assist with participant screening, enrollment, and database maintenance for select clinical trials as needed by working directly with trial participants to align logistics, education, and participation expectations
Communication and Collaboration:
Provide ongoing support to clinical research staff and ensure effective communication regarding regulatory matters between participants, sponsors, and regulatory authorities
Participate in team meetings and contribute to the continuous improvement of clinical trial processes
Qualifications
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
The pay range for this role is:
75,000 - 85,000 USD per year (Remote - United States)
Applied Sciences
Remote (United States)
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