| Manage all aspects of clinical research studies of enrolling autoimmune patients and healthy controls. Manage multiple company clinical study sites and company decentralized digital studies to oversee participant recruitment and enrollment, medical records data extraction, scheduling/follow-up for sample collection and other study requirements as applicable. Oversee adherence to SOPs, Good Clinical Practice, and other applicable industry regulations. Preparation of Institutional Review Board (IRB) protocols, manage the development and implementation of clinical processes, procedures, and programs under the guidance of the Principal Investigator. Manage the collection, analysis, and evaluation of clinical/medical data, production of required progress reports to IRB, granting, and other regulatory agencies. SPECIFIC RESPONSIBILITIES: - Manage the day-to-day activities related to the Company’s clinical research studies and oversee the status of the various stages that the study undergoes
- Supervise the work carried out by the clinical coordinator on all aspects related to Subject Recruitment, Participant Enrollment, and Medical/Clinical Data Extraction and Analysis, and Sample Collection to ensure that these activities are completed on time and per the study protocols
- Assist Principal Investigator in preparing IRB protocols and progress reports to ensure that clinical studies are being conducted in compliance with IRB human subject regulations
- Manage the creation and development of recruitment materials, study protocols, and consent forms for clinical studies
- Assist with strategic planning and budget process related to the studies
- Prepare reports on study timelines and progress and share with internal and external stakeholders as may be required from time to time
- Assist the Principal Investigator with the publication pipeline including initiating potential publications related to ongoing studies and assisting with the creation and editing from draft to final publication
- As needed, performs various duties needed to successfully fulfill the functions of the position
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