General Summary:
The Clinical Research Nurse role is the specialized practice of professional nursing focused on maintaining equilibrium between care of the research participant and fidelity to the research protocol. This specialty practice incorporates human subjects protection, care coordination and continuity, contribution to clinical science, clinical practice and study management throughout a variety of professional roles (i.e., study coordinator, regulatory, monitor), practice settings, and clinical specialties.
The incumbent will work in the Pediatric/Adolescent/Young Adult Oncology department and focuses on research participant screening, enrollment and follow up procedures, risk assessment and other protocol specific activities.
Essential Duties:
- The Clinical Research Nurse ensures human subject protections via diligence in research participant screening, recruitment, consenting, enrollment, monitoring of treatment, and follow-up procedures, ongoing risk assessment related to research interventions and protocol activities.
- Ensures ongoing research informed consent, addresses participant questions throughout study participation and supports their goal for participating or terminating study participation.
- Coordinates research activities to minimize participant risk.
- Distributes study article (drugs, devices), administers study drug, and maintains study article accountability documentation.
- Provides care coordination and continuity, integrating research and clinical activities to meet clinical needs of research participants, coordinates and completes research protocol activities, communicates with referring providers when necessary.
- Facilitates education of research teams related to study requirements.
- Ensures plan of care for research participant is safe and allows for effective collection of clinical research data.
- Documents all study-related procedures/events via electronic data capture systems, case report forms, etc.
- Communicates effectively with research participants and their families, the research team, principal investigators, external study sponsors, primary care providers (e.g., clinical nurses, physicians, etc.), ancillary staff and the IRB to ensure protocol adherence, participant safety and Regulatory compliance.
Standard Requirements:
- BSN required.
- MI Registered Nurse license.
- National research certification (SoCRA or ACRP) within three to five years of hire date required.
- BLS Healthcare Provider Certification through the American Heart Association
- Prior medical/surgical clinical experience required.
- MS Word, Excel, Outlook, and Epic (OneChart) experience required.
- Must demonstrate expert clinical skills, show well-developed critical thinking skills, and integrate knowledge of regulatory, ethical and scientific aspects of clinical research into practice.
- Knowledge of FDA Regulations and Good Clinical Practices
- Clinical Research experience highly preferred.
ACKNOWLEDGEMENT OF EMPLOYMENT UNDER RESEARCH GRANT
Beaumont Health is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, age, status as a protected veteran, or status as a qualified individual with a disability.
