Principal Investigator

Principal Investigator Overview

• The Principal Investigator will lead clinical research activities, focusing on CNS and Cardio-Metabolic programs, ensuring compliance with regulatory standards.
• This role involves supervising research protocols, safeguarding participant welfare, and maintaining data integrity.
• Candidates must hold an MD degree and have at least two years of clinical experience.
• The position offers a structured work schedule, Monday to Friday, 8:00 AM–5:00 PM.
• Responsibilities include oversight of Sub-Investigators and recruitment teams for successful study execution.
• The Principal Investigator ensures adherence to FDA regulations and Good Clinical Practice (GCP) guidelines.
• This role requires bilingual proficiency in English and Spanish, with strong organizational and interpersonal skills.
• The work environment includes exposure to biological fluids, requiring personal protective equipment.

Principal Investigator Key Responsibilities & Duties

• Conduct and supervise clinical research activities, ensuring compliance with protocols and regulatory requirements.
• Perform study-related procedures, including physical exams, informed consent, and adverse event documentation.
• Review and adjudicate laboratory, imaging, and biopsy findings for study participants.
• Coordinate treatment plans and oversee subject health assessments during clinical trials.
• Prepare for study monitor visits and maintain confidentiality of clinical trial data.
• Screen and recruit subjects for clinical trials, ensuring adherence to protocol requirements.
• Provide weekend and after-hours coverage as needed to facilitate study visits.
• Ensure the qualifications and training of delegated team members for research tasks.

Principal Investigator Job Requirements

• Doctor of Medicine (MD) degree with a specialization in Internal Medicine or Geriatrics.
• Minimum of two years of clinical experience; previous PI experience preferred.
• Proficiency in English and Spanish, with excellent written and oral communication skills.
• Strong organizational skills and attention to detail in clinical research settings.
• Knowledge of FDA regulations, Good Clinical Practice (GCP), and IRB protocols.
• Ability to work on-site in a clinical environment, adhering to safety protocols.
• Proficiency in Microsoft Office and web-based enterprise solutions software.
• Flexibility to adapt to changing priorities and provide professional leadership.