Principal Investigator / Medical Director

About the role

The role involves serving as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami, ensuring compliance with GCP guidelines and regulations, and supervising medical services and licensed professional staff.

Responsibilities

• Serve as Principal Investigator or Sub-Investigator on FDA Form 1572 for protocols conducted.
• Comply and adhere to GCP guidelines and regulations.
• Ensure study data is collected in accordance with Good Clinical Practice (GCP) standards.
• Ensure subject safety at all times.
• Directly supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes place.
• Attend to adverse medical events.
• Perform physical exams, read ECG's and review laboratory data for protocols conducted.
• Review screening results as necessary to assemble qualified research participant cohorts according to protocol stipulations.
• Work in concert with site and Clinical Operations to provide supervision and organization of physician, sub-Investigators, nurses and clinical staff.
• Maintain familiarity with crash cart and emergency resuscitation procedures.
• Participate in on-call rotation.
• Review completed data entry and sign-off of completed study documentation in a timely manner, including a careful review and sign-off of adverse assessments, study interim summaries, as well as clinical study reports.
• Participate in writing and editing of protocols and informed consents for clinical studies.
• Be available and participate in communications with sponsor in regard to study progress.
• Be available for FDA inspections and Pharmaceutical Sponsor Audits.

Qualifications

• Active Medical Doctor or Doctor of Osteopathy License, State of Florida.
• Minimum of five years of clinical research experience preferred.
• Board Certified in a medical specialty.
• Not debarred, disqualified, or restricted by the FDA or State of Florida.
• Maintains BLS and ACLS certification.
• Maintains CITI Program certification.