Sub-Investigator
Reports to: Principal Investigator
Job Summary: To apply medical knowledge and experience, under the direction of the onsite clinician 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. Will assist with management of patients within the Liver Institute.
Under the direction of the Principal Investigator, responsibilities will include, identify and recruitment of participants, obtaining informed consent, management of protocol related procedures, perform phlebotomies and insertion of IVs, prepare and maintain source documentation for phase 1-3 studies implemented at the Center. 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.
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.
· Follow patient’s workup and maintenance labs and therapy.
· Communicate with FDHS partner when indicated.
· Assist with all prior authorization; labs, procedures and medicines.
QUALIFICATIONS AND REQUIREMENTS
· Licensed Nurse Practitioner or Licensed Physician’s Assistant
· Maintenance of FDA license
· Requires a thorough knowledge of the: Drug development process, Clinical trial management, Clinical monitoring, FDA regulations, ICH Good Clinical Practice, and Good Documentation Practice, HIPAA
· Phlebotomy skills
· 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.
- Demonstrates problem solving techniques.
- 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
All duties are subject to change and/or be modified by Principal Investigator or Site Director.