Principal Investigator

Principal Investigator Overview

• The Principal Investigator oversees clinical trial activities, ensuring adherence to ICH/FDA/GCP guidelines and local regulations.
• Conducts clinical oversight and ensures the quality of assigned studies at the site.
• Collaborates with local and central teams to drive participant safety and protocol compliance.
• Evaluates participant eligibility and ensures ethical execution of clinical trials.
• Provides leadership to enhance site efficiencies and regulatory adherence.
• Participates in staff training, investigator meetings, and continuing education activities.
• Maintains detailed records and ensures data integrity following protocol guidelines.
• Engages positively with sponsors, clients, and team members to ensure successful study delivery.
• Supports retention strategies for study participants and ensures their medical well-being.

Principal Investigator Key Responsibilities & Duties

• Ensure participant safety and ethical execution of clinical trials.
• Evaluate participant eligibility and oversee enrollment processes.
• Collaborate with sponsors and team members to ensure protocol compliance.
• Maintain accurate and detailed records following GCP guidelines.
• Provide training and mentorship to staff on protocol requirements.
• Participate in investigator meetings and educational activities to stay updated.
• Lead site operations to enhance efficiencies and regulatory adherence.
• Handle sensitive information professionally and in compliance with HIPAA guidelines.
• Adapt to workload changes and prioritize tasks effectively.

Principal Investigator Job Requirements

• Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree required.
• Active physician license in good standing within the state of practice.
• Minimum 2 years of clinical trial experience; 4 years preferred.
• Board certification in area of specialty is mandatory.
• Proficiency in MS Office, electronic health records, and web applications.
• Strong organizational, communication, and interpersonal skills.
• Ability to handle sensitive information confidentially and professionally.
• Bilingual proficiency in English and Spanish is highly preferred.
• CPR certification required; ACLS certification preferred.