Principal Investigator

How This Role Makes a Difference

We are seeking a highly skilled and experienced part-time Principal Investigator to join our team. As the Principal Investigator, you will be responsible for oversight of all clinical trials according to study protocols, company processes, and GCP. Please note this is a part-time role.

How You'll Make An Impact

• Provide overall medical oversight and medical review of protocols in conformance with good clinical practice
• Review sponsor provided safety reports
• Review and maintain accurate case report forms
• Ensure that the safety and well-being of all participants in the study at the trial site are protected
• Assess subject response to therapy, evaluate and address adverse experiences
• Perform physical assessments, examinations and study procedures as required by study protocols
• Train Sub-Investigators and study staff members on protocol and protocol specific procedures
• Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility
• Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team
• Complete the necessary Care Access and protocol specific trainings
• Comply with ICH GCP and all applicable regulatory requirements
• Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies

The Expertise Required

• Excellent written and verbal communication skills
• Ability to effectively prioritize tasks in a fast-paced environment
• Attention to detail and ability to maintain confidentiality when handling sensitive information
• Critical thinking, dynamic problem-solving skills

Certifications/Licenses, Education, and Experience

• Minimum Education: MD or DO with an active, unrestricted medical license (medical license must be valid in the state in which the research is conducted)
• Minimum Experience: Previous experience as a Principal Investigator is required; 2 years prior experience as a Principal Investigator or Sub-Investigator, preferred
• Training and certification in Good Clinical Practice (GCP)

How We Work Together

Location: Brandon, FL. This role requires 100% of work to be performed on site. This is an onsite position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.