We are looking for a Principal Investigator (PI) to lead the management of clinical trials focused on Alzheimer’s Disease at our Neurology research sites. The PI will be responsible for overseeing all aspects of trial execution, ensuring adherence to ICH/GCP guidelines and FDA regulations, and prioritizing participant safety, data accuracy, and protocol compliance. The ideal candidate is a Board-Certified Neurologist with experience as a PI in Alzheimer’s Disease trials.
*Relocation Assistance may be offered
In this role, the PI will work closely with operational teams, clinical coordinators, and external sponsors to ensure the successful implementation of high-quality clinical trials. The position requires clinical oversight of trial protocols, patient care, and timely communication with sponsors and regulatory bodies.
Responsibilities:
- Provide clinical oversight for all Alzheimer’s Disease trials at assigned Neurology sites.
- Act as the Principal Investigator for clinical trials, ensuring compliance with protocols, ethical standards, and regulatory requirements (FDA, GCP).
- Review and approve study protocols, informed consent forms, and other relevant documents.
- Collaborate with the feasibility team to determine enrollment potential based on protocol specifications.
- Engage and recruit eligible participants, ensuring patient safety and proper monitoring throughout the trial.
- Review patient medical history and perform assessments necessary for trial inclusion.
- Collaborate with site staff, clinical research coordinators, and monitors to ensure timely and accurate data collection.
- Interface with sponsors, CROs, and internal operations teams to align 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 the assigned state with no open or past action items.
- Deep knowledge of clinical research processes, FDA regulations, ICH/GCP guidelines, and 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 and the ability to manage multiple projects simultaneously.
- Excellent written and oral communication skills for reporting and interacting 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 effectively 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.
