Reports to: Principal Investigator and Director of Site Operations
Job Summary:
To apply medical knowledge and experience, under the direction of the Principal Investigator to oversee and direct clinical course of research participants in clinical trials. Assess physical health and administer treatments throughout the study aligned with scope of practice delegated responsibilities. Oversee study conduct and assure study participant safety. Coordinate and manage care for participants enrolled in a clinical research trial. The sub investigator will be responsible for overseeing the execution of study protocols, delegating study related duties to site staff and ensuring site compliance with study protocols, study-specific laboratory procedures, standard operating procedures, standards of Good Clinical Practice (GCP), adhering to OSHA guidelines and other state and local regulations as applicable.
Under the direction of the Director of the Principal Investigator, responsibilities will include, identify and recruitment of participants, participate in study visits, communicate with families, participants, referring physicians and other health care providers, Educating and guidance to participants and families to ensure compliance and retention of study participants, tracking and recording of adverse events, perform physical exams to ensure enrollment criteria and to track for any changes during study participation, diagnose and treat medical conditions such as allergic reactions and anaphylaxis during study drug administration, exacerbations of illness, formulate and evaluate treatment plans, manage common conditions such as allergic rhinitis, asthma and eczema, review home diaries and be available for on call advice and emergencies between clinic visits, administer rescue medications based on clinical judgment.
Job Details:

• Part-time (3 Days) Monday – Friday
• No Weekends
• No Holidays
• No On-Call

Duties include but 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; 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 may also be assigned

QUALIFICATIONS AND REQUIREMENTS

• Medical degree with current medical licensure 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, and Good Documentation Practice, HIPAA

• Current Basic CPR certification

OTHER SKILLS AND ABILITIES:

• Team player - Effective participant as a team member and team leader. Can demonstrate significant positive participation on successful teams.

• Professionalism and integrity - Able to adapt to a changing environment and demonstrates a “make it happen” attitude. Exhibits professionalism in negotiating sensitive issues. Exhibits professionalism in negotiating sensitive issues.

• 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. Ability to write clear, concise and convincing memos, letters and articles using original or innovative techniques or style.

• 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.

• 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

All duties are subject to change and/or be modified by Principal Investigator or Director of Site Operations