Principal Investigator

Principal Investigator Overview

• The Principal Investigator oversees clinical trial activities, ensuring adherence to FDA, ICH, GCP, and HIPAA guidelines.
• Collaborates with local and central teams to enhance clinical oversight and study quality at the site.
• Evaluates participant eligibility, ensuring safe and ethical trial execution.
• Provides leadership to ensure compliance with protocols and regulatory standards.
• Engages in participant recruitment, retention, and successful study delivery.
• Participates in training sessions and investigator meetings to maintain current knowledge.
• Handles sensitive information confidentially, adhering to HIPAA guidelines.
• Supports the team with protocol training and operational efficiency improvements.

Principal Investigator Key Responsibilities & Duties

• Ensure participant safety and ethical conduct of clinical trials.
• Lead site operations, focusing on efficiency and regulatory compliance.
• Evaluate participant eligibility and oversee enrollment processes.
• Collaborate with sponsors, clients, and team members for trial success.
• Maintain accurate records and adhere to protocol guidelines.
• Conduct staff training on protocols and procedures.
• Participate in investigator meetings and continuing education activities.
• Adapt to workload changes and prioritize tasks effectively.

Principal Investigator Job Requirements

• Doctor of Medicine (MD) degree and active physician license in good standing.
• Minimum of 2 years of experience; 3 years preferred.
• Board certification in area of specialty required.
• Proficiency with MS Office, EHR systems, and web applications.
• Strong organizational skills, attention to detail, and communication abilities.
• Bilingual proficiency in English and Spanish highly preferred.
• CPR certification required; ACLS preferred.
• Ability to handle sensitive information confidentially and professionally.