The Nurse Practitioner provides clinical expertise for Phase I trials, performing physical exams and participant assessments. They ensure adherence to GCP, FDA, and ICH regulations while serving as a technical advisor to clinical pharmacology teams.
Requirements summary
Candidates must be graduates of an accredited Nurse Practitioner program with current NP certification and active licensure. A minimum of 3 to 5 years of relevant clinical experience is required.
professional certificatepostgraduate degreeMentoringRegulatory CompliancePhysical ExaminationsMedical HistoriesPatient SafetyData IntegrityFDA RegulationsGood Clinical Practice (GCP)Technical AdvisingICH RegulationsClinical PharmacologyClinical Trial ExecutionParticipant AssessmentsClinical Feasibility Assessments
Job description
Come join Fortrea today as a Nurse Practitioner with our Phase I site based in Dallas, Texas.
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 Why Fortrea?
At Fortrea, you’ll contribute to advancing clinical development and improving patient outcomes through meaningful work in early-phase research.
This role offers a collaborative, fast-paced environment with opportunities to expand your clinical expertise and impact global healthcare innovation. #LI-SE1 Learn more about our EEO & Accommodations request here.
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