Description
Position: Principal Investigator, Neurology – Alzheimer's Disease (Full-Time/Exempt)
Company Overview: Our client is a leading U.S. clinical trial site network, conducting Phase I-IV pharmaceutical and medical device clinical trials in physician offices. They partner with practicing physicians to provide biopharma and CRO clients with access to diverse patient populations, excelling in patient identification, enrollment, and retention.
Position Overview: The Principal Investigator (PI) will lead Alzheimer's Disease clinical trials at Tekton's Neurology research sites. Responsibilities include overseeing clinical trial conduct, ensuring compliance with ICH/GCP guidelines and FDA regulations, patient safety, and data integrity.
Reports to: Chief Medical Officer (CMO)
Job Description:
- Provide clinical oversight for all Alzheimer's Disease trials.
- Ensure compliance with protocols, ethical standards, and regulatory requirements.
- Review and approve study protocols, informed consent forms, and relevant documents.
- Work with the feasibility team to determine enrollment potential.
- Engage and recruit eligible participants, ensuring patient safety and proper monitoring.
- Review patient medical histories and perform necessary assessments.
- Collaborate with site staff, clinical research coordinators, and monitors.
- Interface with sponsors, CROs, and operational teams to align on study objectives.
- Lead review meetings to track study progress and resolve issues.
- Ensure accuracy in clinical data and provide clinical interpretation where necessary.
- Evaluate and document adverse events, adhering to reporting requirements.
- Educate and lead clinical and research staff on Alzheimer's Disease trials.
Required Skills/Abilities:
- Board certification in Neurology, subspecialty in Alzheimer's Disease preferred.
- Active Medical License with no open or past actions.
- 5+ years of experience as a Principal Investigator; 3+ years in Alzheimer's Disease trials.
- Deep knowledge of clinical research processes, FDA regulations, ICH/GCP guidelines.
- Proven patient and clinical staff engagement skills.
- Strong organizational skills and ability to manage multiple projects.
- Excellent communication skills.
- Experience in patient recruitment and retention.
- Familiarity with electronic data capture and clinical trial management software.
- Ability to work in a fast-paced environment and collaborate effectively.
- Willingness to relocate if required.
Education and Experience:
- M.D. or D.O. degree with board certification in Neurology.
- Extensive clinical and research experience in Alzheimer's Disease.
- Prior PI experience in Alzheimer's Disease clinical trials.
Physical Requirements:
- Prolonged periods of desk work and computer use.
- Occasional travel for meetings and conferences.
- Ability to conduct patient examinations and assessments.
Compensation: Competitive salary and benefits package, including professional growth opportunities and participation in industry conferences and scientific publications.
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