Reports to:

Job Summary:

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; 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