Physician Assistant (Clinical Research)

About the role

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.

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.
• 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.
• 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 Physician Assistant.
• Active and unencumbered license to practice as a Physician Assistant in the state of Arizona.
• 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.