Sub Investigator - APRN/PA

We are seeking a Sub-Investigator at Florida Research Institute (FRI), a global leader in gastroenterology and hepatology research, with a team of more than 20 highly trained clinical research experts. The Sub-Investigator will apply medical knowledge and experience under the direction of the Principal Investigator to oversee and direct the clinical course of research participants in clinical trials. The Sub-Investigator will assess physical health and administer treatments throughout the study aligned with scope of practice delegated responsibilities, oversee study conduct, and assure participant safety. Responsibilities include: 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; obtain complete study participant history, conduct physical exams, review medical charts, assess findings, prescribe and re-fill medication, and perform designated procedures according to written protocols. 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. Coordinate and collaborate with principal investigator to review study protocol. Identify, recruit, and enroll study participants, as well as maintain study participant records; determine study participant criteria Support sponsor investigator research with investigational new drug/investigational device exemption applications Communicate with FDHS partner when indicated Guidance of medical assistance team Management of patient medical and scheduling issues when indicated Other duties as assigned: Duties are subject to change or be modified by Principal Investigator or Director of Site Operations Qualifications Licensed Advanced Practice Registered Nurse (APRN) or Physician Assistant (PA) with an active, unrestricted license in the state of Florida is required Requires a thorough knowledge of the drug development process, clinical trial management, study team management, clinical monitoring, FDA regulations, ICH Good Clinical Practice, good documentation practice, and HIPAA Current Basic CPR certification Team player – effective participant as a team member and team leader, with a positive attitude Professionalism and integrity – able to adapt to a changing environment and demonstrates a "make it happen" attitude Problem solving techniques Managing study team members to maintain clinic workflow and study organization Interpersonal interaction – demonstrates excellent people skills and a positive attitude Communication – effective verbal communication and presentation skills, and ability to write clear, concise and convincing memos, letters and articles Ability to prioritize and to manage multiple tasks as necessary Attention to detail – produces high-quality, accurate work with minimal supervision Flexibility – ability to adapt and be willing to assist with achieving company goals in the area of responsibility and time Working Conditions May be required to work with, take specific precautions against, and/or be immunized against potentially hazardous agents May be exposed to blood-borne pathogens Available for call 24 hours/day Frequent travel possible for IM meetings and assistance with FRI growth projects and satellites Attend national congress when indicated Considerations for AASLD fellowship Manage study team members Competitive salary commensurate with experience. Comprehensive benefits package including health insurance, free telehealth, retirement plan, paid time off and paid holidays. Positive and collaborative work environment EEO Statement It is the policy of Florida Digestive Health Specialists to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. #J-18808-Ljbffr Florida Digestive Health Specialists