Principal Investigator (PI) promotes Good Clinical Practice in the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents.

Primary Responsibilities:

• The PI assumes full responsibility for a clinical trial, including the oversight and ethical conduct of the study, maintaining integrity of the study design, and direction of the research team to ensure research is conducted in accordance with the local and national laws and regulations, including applicable FDA regulations, GCP, ICH guidelines, HIPAA, and all policies and procedures of the Sponsor, CRO and Site
• Evaluate patient eligibility for a clinical trial as per protocol
• Review and discuss study protocols and obtain (or delegate) informed consents from subjects
• Meet with subjects during designated study visits to perform assessments, including physical examinations and data collection
• Review and interpret laboratory results, EKGs and other diagnostic and safety assessments as required per study protocol
• Monitor all safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medications as per protocol, and un-blinding requests
• Use proper medical judgment in the interpretation and decision-making as it relates to the investigational study
• Review, approve and ensure timely reporting of eCRFs, protocol deviations and Serious Adverse Events (SAE)
• Ensure accurate documentation of study-related procedures
• Ensure proper use and storage of Investigational Product
• Ensure prompt reporting all unanticipated problems or injuries to IRB, Sponsor, or delegated representative
• Meet with FDA, IRB, Sponsors, CROs, or their delegated representatives as needed throughout the study
• Review and discuss any medical or protocol-related inquiries with medical monitors
• Attend Investigator Meetings and other study-related meetings
• Work with Sub-investigator(s), Clinical Research Coordinators, and key study personnel in overseeing the execution of study protocols

Knowledge, Skills, and Abilities:

• Broad knowledge of general medicine
• Strong analytical and problem-solving skills
• Excellent organizational skills, detail oriented, efficient, and able to multi-task and prioritize effectively
• Excellent interpersonal skills
• Strong written and verbal communication skills
• In depth knowledge of GCP and ALCOA-C

Qualifications:

• Medical Degree and broad-based post-graduate experience
• Medical License within the State of Florida
• A minimum of 3 or more years of experience in a clinical research position
• Principal Investigator of Clinical Trials: 3 years (Required); experience in all phases of clinical trials preferred.
• Bi-lingual in English and Spanish