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.