Principal Investigator

The Principal Investigator (PI) is responsible for the overall conduct of clinical trials at the site. The PI ensures studies are carried out in compliance with the study protocol, Good Clinical Practice (GCP), and all applicable regulations, while safeguarding the rights, safety, and well-being of study participants.

Key Responsibilities

• Provide medical oversight for clinical trials conducted at the site.
• Ensure the study is conducted according to the approved protocol and regulatory requirements.
• Screen, assess, and enrol eligible participants into clinical trials.
• Obtain and document informed consent from study participants.
• Conduct and document study-related medical assessments.
• Review and sign off on study documentation, including case report forms and safety reports.
• Ensure accurate reporting and prompt follow-up of adverse events.
• Supervise and guide site research staff to ensure high-quality trial conduct.
• Maintain study records and ensure audit / inspection readiness.
• Act as the primary contact for sponsors, monitors, and regulatory bodies regarding trial conduct at the site.

Qualifications

• Medical degree (MD, DO, or equivalent) with active license to practice.
• Previous experience in clinical research preferred.
• Knowledge of GCP and applicable regulatory guidelines.
• Strong communication and leadership skills.