Principal Investigator

The Principal Investigator conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Working with a local and central team drives clinical oversight and the quality of the assigned studies at the site.

Key Responsibilities

Essential Job Duties:

• Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes 
• Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP /regulatory compliance
• Evaluates and assesses participants to ensure only eligible participants enroll into the trials.
• Participates and engages in successful delivery and retention of study participants.
• Interacts positively and collaboratively with sponsors, clients and team members.
• Practices attention to detail in recording data and participant information, following protocol guidelines and GCPs.
• Actively involved in protocol training for staff.
• Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current knowledge of recruitment affairs and issues.
• Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company.