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Sub-Investigator (Part-time)

Reports to:
Principal Investigator and Senior Director of Clinical Research and Development
Job Summary:

Under the direction of the Principal Investigator, the Sub-Investigator will apply medical knowledge and experience to oversee and direct the clinical course of research participants in clinical trials. Also, assess physical health and administer treatments throughout the study that are aligned with the scope of practice and delegated responsibilities. 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, ensuring patient safety, 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 Senior Director of Clinical Research and Development or the Principal Investigator, responsibilities will include identifying and recruitment participants, participating in study visits, communicating with families and participants, referring physicians and other health care providers, and educating and guiding 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 are not limited to:
  • Ensure the safety of study participants and maintain communication with patients, Florida Research Institute (FRI) team members, and clinicians
  • Provide clinical and medical support and oversight for research clinical trials based on the 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 the Principal Investigator to review the study protocol
  • Assist the recruitment team in identifying, recruiting, and enrolling study participants, maintain study participant records, and determine study participant criteria
  • Support sponsor investigator research with investigational new drug/investigational device exemption applications
  • Communicate with the study participant’s referring physician when indicated
  • Guidance of the medical assistance team
  • Management of patient medical and scheduling issues when indicated
  • Other duties may also be assigned
Knowledge, 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 demonstrate a “make it happen” attitude. 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 styles
  • Ability to prioritize and 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 terms of responsibility and time
Education and Experience
  • Medical Degree
  • 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, HIPAA
  • Active licensure as a Nurse Practitioner (NP) or Physician Assistant (PA) in Florida is required
  • Current Basic CPR certification
  • DEA License
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

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

    • Part-time – 3 days a week (Monday – Friday)
    • No Weekends
    • No Holidays
    • No On-Call

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