Graduate of an accredited Nurse Practitioner program
Current NP certification and active licensure
Equivalent combination of education and relevant experience may be considered
Strong English communication skills (spoken and written)
3-5 years of relevant clinical experience
Responsibilities
Perform physical examinations and participant assessments as delegated by the Medical Director
Interact with regulatory bodies regarding operational activities
Serve as a technical advisor to Clinical Pharmacology teams
Support the improvement of clinical processes and facilities
Participate in clinical feasibility assessments for new studies
Oversee development and implementation of quality systems to meet GCP standards
Ensure compliance with FDA, GCP, and ICH regulations
Support sponsor visits and interactions with operations
Promote a safe working environment and recommend improvements
Attend investigator meetings as needed
Provide training and mentorship to staff
Benefits
Professional growth opportunities within a collaborative environment
Exposure to cutting-edge clinical research and trial methodologies
Access to continuous training and development resources
Commitment to high standards of participant safety and regulatory compliance
Opportunity to be part of a reputable Phase I clinical site in a dynamic location
Full Job Description
Come join Fortrea today as a Nurse Practitioner with our Phase I site based in Madison, Wisconsin. The NP - Nurse Practitioner provides clinical expertise and serves as a key knowledge resource for the clinical aspects of trials conducted within Clinical Pharmacology. This role supports the execution of clinical studies and may function as a sub-investigator, ensuring high standards of participant safety, data integrity, and regulatory compliance.
Summary of Responsibilities
Perform physical examinations, medical histories, and participant assessments as delegated by the Medical Director
Interact with regulatory bodies as relevant to operational activities
Serve as a technical advisor to Clinical Pharmacology teams and cross-functional partners
Support the maintenance and continuous improvement of clinical processes and facilities
Participate in clinical feasibility assessments for new study proposals
Oversee and contribute to the development and implementation of quality systems to ensure adherence to Good Clinical Practice (GCP)
Ensure compliance with FDA, GCP, and ICH regulations
Perform routine study-related activities as required
Support sponsor visits and interactions in collaboration with operations and client management
Promote and maintain a safe working environment; recommend improvements as appropriate
Attend investigator meetings as needed
Serve as an educational resource, trainer, and mentor to staff
Perform additional duties as assigned
Qualifications (Minimum Required)
Graduate of an accredited Nurse Practitioner program
Current NP certification and active licensure
Equivalent combination of education and relevant experience may be considered
Strong English communication skills (spoken and written)
Experience (Minimum Required)
3-5 years of relevant clinical experience
Physical Demands / Work Environment
Work is performed in a clinical and/or laboratory environment with potential exposure to biological, hazardous, or radioactive materials
Ability to distinguish colors and hear clearly
Ability to use hands for extended periods (up to 6 hours/day) for clinical and computer-based tasks
Ability to stand, walk, bend, and perform repetitive movements for extended periods (up to 6 hours/day)
Flexibility to work overtime or weekends as needed
Travel Requirements
Occasional travel may be required for investigator meetings, cross-site support, or training
