Location: all cities,TX, USA
Tekton Research is looking for a Principal Investigator (Neurology) to join our team in Austin, TX!
The Principal Investigator (PI) will lead the execution of clinical trials in Alzheimer's Disease at Tekton's assigned Neurology research sites. 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 Tekton'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 Alzheimer's Disease trials at Tekton's Neurology sites.
• Acts as the Principal Investigator for 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 Tekton's operations team to ensure alignment on
study objectives and timelines.
Required Skills/Abilities:
• Board certification in Neurology, with a subspecialty focus on Alzheimer's 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.
Education and Experience:
• M.D. or D.O. degree with board certification in Neurology.
• Extensive clinical and research experience in Alzheimer's Disease.
• Prior experience as a PI in Alzheimer's Disease clinical trials.