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The Principal Investigator (PI) will lead the execution of clinical trials in Alzheimers Disease at the assigned Neurology research sites of our clinical trial site network client. The PI will oversee all aspects of clinical trial conduct in compliance with ICH/GCP guidelines and FDA regulations, ensuring the safety of participants, integrity of data collected, and compliance with study protocols. The ideal candidate is a Board-Certified Neurologist with significant experience as a PI in Alzheimer's Disease trials.As a PI, you will collaborate with the site's operational teams, clinical coordinators, and external sponsors to execute high-quality clinical trials. This position requires clinical oversight of trial protocols, patient management, and timely reporting to sponsors and regulatory agencies.Job Description: Provides clinical oversight for all Alzheimers Disease trials at our client's Neurology sites. Acts as the Principal Investigator for our client's clinical trials, ensuring compliance with protocols, ethical standards, and regulatory requirements (FDA, GCP). Reviews and approves study protocols, informed consent forms, and other relevant documents. Works with feasibility team to determine the enrollment potential for the site according to the protocol specifications. Engages and recruits eligible participants, ensuring patient safety and proper monitoring throughout the trial. Reviews patient medical history and performs assessments necessary for inclusion in clinical trials. Collaborates with site staff, clinical research coordinators, and monitors to ensure timely and accurate data collection. Interfaces with sponsors, CROs, and our operations team to ensure alignment onstudy objectives and timelines.Required Skills/Abilities: Board certification in Neurology, with a subspecialty focus on Alzheimers Disease preferred. Active Medical License in assigned state with no open or past action items. 5+ years of experience as a Principal Investigator in clinical trials, with at least 3 years in Alzheimer's Disease trials. Deep knowledge of clinical research processes, FDA regulations, ICH/GCP guidelines, and relevant ethical standards. Proven ability to engage with patients and clinical staff to maintain a high standard of care in a research setting. Strong organizational skills with a demonstrated ability to manage multiple projects simultaneously. Excellent written and oral communication skills for reporting and interaction with sponsors and clinical staff. Experience in patient recruitment and retention in clinical trials. Familiarity with electronic data capture systems and clinical trial management software. Ability to work in a fast paced environment and collaborate with site staff.
Date Posted: 13 April 2025
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