Nurse Practitioner (Clinical Research)

Nurse Practitioner (Clinical Research)

This role serves as a Clinical Research Sub-Investigator within a Good Clinical Practice (GCP)-compliant clinical trial environment, providing direct patient care while supporting the safe and accurate conduct of clinical studies. The Clinical Research Nurse Practitioner conducts or assists with clinical trials in alignment with trial-specific protocols, standard operating procedures, and local regulations. The position focuses on delivering high-quality medical care to study participants, ensuring protocol adherence, and maintaining meticulous documentation throughout the research process.

Responsibilities

• Conduct study activities as delegated by the Principal Investigator and Study Project Manager in strict compliance with the study protocol, GCP guidelines, and applicable FDA regulations.
• Perform vital signs assessments, physical examinations, and other clinical procedures in accordance with trial protocols.
• Perform phlebotomy and ensure safe and accurate collection, handling, and labeling of blood samples.
• Order diagnostic tests and procedures as required by the protocol and coordinate with collaborating clinical departments and specialists according to the trial schedule of activities.
• Oversee study drug and treatment processes, including investigational product dispensation, preparation, and administration.
• Maintain accurate study drug documentation, including logs, worksheets, and labels, to ensure traceability and regulatory compliance.
• Monitor and record patient responses to treatment, including adverse events (AEs) and serious adverse events (SAEs), and ensure timely reporting.
• Coordinate medical questions and clinical procedures with the Principal Investigator and other study sub-investigators.
• Coordinate patient treatment and adverse event management plans with investigators and the Medical Director.
• Ensure accurate, detailed, and timely documentation of all study-related activities, including completion of case report forms (electronic and/or paper) and maintenance of source documentation.
• Prescribe medications and other treatments as necessary within scope of practice and in accordance with study protocols and applicable regulations.
• Discuss clinical trial participation with potential participants and obtain informed consent in accordance with ICH GCP guidelines and internal standard operating procedures.
• Handle medical emergencies in accordance with study protocols, internal procedures, and applicable regulations, ensuring participant safety.
• Assist with study feasibility reviews and provide medical and scientific feedback on trial protocols, publications, and study records.
• Collaborate with study coordinators to ensure proper study setup, including adequate inventory of investigational product, ancillary medications, and study supplies.
• Assist with patient recruitment, pre-screening, screening, and retention efforts to support enrollment goals.
• Participate in the review and development of internal documentation such as standard operating procedures, working instructions, forms, and templates.
• Participate in monitoring visits, audits, and inspections by sponsors and regulatory or oversight agencies to support verification of data accuracy and quality.
• Perform clinical chart reviews and pre-screening of patients to identify eligible participants based on protocol criteria.
• Contribute to oncology-related clinical research activities as applicable, ensuring adherence to oncology-specific protocols and safety standards.
• Perform other related duties as assigned to support the successful execution of clinical trials.

Essential Skills

• Clinical research experience with direct involvement in the conduct of clinical trials.
• Proficiency in clinical chart review and patient pre-screening for study eligibility.
• Ability to perform and interpret vital signs, physical examinations, and routine clinical procedures.
• Competence in phlebotomy and handling of blood samples in a research setting.
• Knowledge of and adherence to Good Clinical Practice (GCP) guidelines.
• Familiarity with oncology clinical research and oncology patient care, as applicable.
• Strong understanding of FDA regulations and clinical trial protocols.
• Ability to order and interpret diagnostic tests and coordinate care with collaborating departments and specialists.
• Skill in monitoring and documenting patient responses, adverse events (AEs), and serious adverse events (SAEs).
• Experience overseeing study drug dispensation, preparation, administration, and related documentation.
• Strong documentation skills, including completion of case report forms (electronic and paper) and maintenance of accurate source records.
• Ability to obtain informed consent in accordance with ICH GCP and internal standard operating procedures.
• Capability to handle medical emergencies in a clinical research setting following established protocols.
• Master's degree in Nursing (MSN) from an accredited institution with advanced clinical training.
• Minimum of 1 year of experience as a nurse practitioner.
• Active and unencumbered license to practice as a registered nurse in the state of Arizona.
• National Nurse Practitioner certification.
• Strong communication and collaboration skills for working with investigators, coordinators, and multidisciplinary teams.
• Ability to stand and walk for extended periods and safely handle average-weight objects up to 35 pounds.

Additional Skills & Qualifications

• Experience participating in study feasibility assessments and providing medical and scientific feedback on trial protocols and study documents.
• Experience assisting with patient recruitment, screening, and retention strategies in a clinical research environment.
• Familiarity with the development and review of standard operating procedures, working instructions, forms, and templates.
• Experience participating in monitoring visits, audits, and inspections by sponsors or regulatory bodies.
• Exposure to or experience in oncology clinical trials.
• Ability to work independently while maintaining strong attention to detail and compliance with regulatory requirements.
• Comfort working with electronic and paper-based case report forms and clinical documentation systems.
• Strong organizational skills to manage multiple study-related tasks and timelines.

Work Environment

This position is based on site in a medical and clinical environment in Phoenix, Arizona. The role requires commuting to a busy, high-traffic urban area, so candidates should consider travel time and distance when applying. Work is performed in a clinical research facility that adheres to strict safety and quality standards. The role involves moderate physical activity, including handling average-weight objects up to 35 pounds and standing and/or walking for more than four hours per day. The position requires working closely with patients, clinical staff, and research teams in a structured, protocol-driven setting that emphasizes accuracy, patient safety, and regulatory compliance.