Lead a research facility with a team of healthcare professionals. Florida Research Institute is a multi-therapeutic, dedicated clinical research site with an industry track record of providing high performance rates and quality data. We are searching for a principal investigator to apply medical knowledge/experience to oversee and direct the clinical course of research participants in Sponsor-initiated clinical trials. This individual will be responsible for assuring the site meets study screening and randomization goals while maintaining low screen failure rates.
The person in this role must have a thorough knowledge of Sponsor-initiated clinical trial management and monitoring, as they will be responsible for working with the sub-investigator in overseeing the execution of strict study protocols, training and delegating study-related duties to site staff and ensuring site compliance with study protocols, Standard Operating Procedures, (SOP’s), Standards of Good Clinical Practice, (GCP), adhering to OSHA guidelines and other state/local regulations as applicable.
The principal investigator will also help assess physical health and administer treatments throughout the study aligned with scope of practice delegated responsibilities. Additionally, they will oversee study conduct and assure study participant safety.
Duties include but are not limited to:
- Ensure the safety of study participants, and maintain communication with patients, FRI team members and clinicians.
- Provide clinical and medical support and oversight for research clinical trials based on scope of practice.
- Collaborate with clinical staff, researchers, outside vendors, and other staff to administer treatment and study protocols.
- Assess, grade, and document adverse events; apply triage and judgment to determine course of action.
- Oversee and, as needed, administer medications and treatments per study protocol and scope of practice.
- Comply with institutional policies, standard operating procedures, and guidelines; prepare and submit documentation as required by the study protocol and study sponsor; interpret complex protocols.
- Identify, recruit, and enroll study participants, as well as maintain study participant records and determine study participant criteria.
- Activily interface with providers of Florida Digestive Health Specialist, (FDHS) to educate and advise on the enrolling trials.
- Support sponsor investigator research with investigational new drug/investigational device exemption applications.
QUALIFICATIONS AND REQUIREMENTS
- Medical degree with current medical licensure in the state of Florida
- Internal medicine physician preferred
- Thorough knowledge of the: Drug development process, Clinical trial management, study team management, Clinical monitoring, FDA regulations, ICH Good Clinical Practice, and Good Documentation Practice, HIPAA
- Current ACLS certification
LIVING IN MANATEE COUNTY
With warm temperatures, award-winning beaches and a thriving cultural and arts scene, Lakewood Ranch is the perfect place for families of all sizes. This idyllic southwest Florida community, which is about an hour from Tampa and two hours from Orlando, continues to flourish and attract new residents with a burgeoning economy, great restaurants and plenty of year-round activities.