Job Description
Clinical Research Nurse Practitioner- Sub Investigator
Key Responsibilities
- Serve as the Sub Investigator and conduct study activities as delegated by the Principal Investigator and Study Project Manager, in compliance with study protocols and applicable FDA regulations.
- Perform vital signs assessments, physical examinations, phlebotomy, and other clinical procedures as required by trial protocols.
- Order diagnostic tests and liaise with clinical departments and specialists according to the trial schedule.
- Oversee study drug dispensation, preparation, administration, and maintain accurate study drug logs and documentation.
- Monitor and record patient responses to treatment, adverse events (AEs), and serious adverse events (SAEs).
- Coordinate medical procedures and patient treatment plans with investigators and the Medical Director.
- Ensure precise and timely documentation, including completion of Case Report Forms (CRFs) and maintenance of source documentation.
- Prescribe medications and treatments as necessary and obtain informed consent from trial participants in accordance with ICH GCP and Arensia SOPs.
- Handle medical emergencies in accordance with study protocols and applicable regulations.
- Assist with study feasibility reviews and provide medical and scientific feedback on trial protocols and study records.
- Collaborate with study coordinators to ensure proper trial setup and adequate inventory of investigational products and study supplies.
- Participate in patient recruitment, screening, and retention efforts.
- Contribute to the development and review of internal documentation, including SOPs and templates.
- Participate in monitoring visits, audits, and inspections by sponsors and related agencies to ensure data accuracy and quality.
- Perform other duties as assigned.
Qualifications
- Master's degree in Nursing (MSN) from an accredited institution with advanced clinical training.
- Minimum of one year of experience as a nurse practitioner.
- Active and unencumbered license to practice as a registered nurse in Arizona.
- National NP Certification.
- Experience with clinical research principles and procedures.
- Familiarity with instruments and equipment commonly used in clinical research.
- Understanding of ethical principles and federal and state regulations governing human subjects in clinical research.
- Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures.
- CPR/ACLS certification, GCP, and IATA training (initial certifications and recertifications supported by ARENSIA).
- Proficiency in the Spanish language is advantageous.
Pay and Benefits
The pay range for this position is $120000.00 - $200000.00/yr.
- Four weeks of paid vacation each year of employment - Up to two weeks paid leave due to illness each calendar year- Up to two weeks paid leave each calendar year to care for an immediate family member who has a serious health condition- 401(k) plan, including a 3% non-elective employer contribution- Option to opt into the following types of insurance coverage:- medical- dental- vision- critical illness supplemental coverage- medical insurance gap- life- accident coverage
Workplace Type
This is a fully onsite position in Phoenix,AZ.
Application Deadline
This position is anticipated to close on Jun 13, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Job Tags
Local area, Immediate start,
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