The Principal Investigator (PI)

Job Description:

• 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 operations team to ensure alignment on

study objectives and timelines.

Required Skills/Abilities:

• Board certification

• Active Medical License in assigned state with no open or past action items.

• 5+ years of experience as a Principal Investigator in clinical 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

• Prior experience as a PI