RN Clinical Research Pediatric Oncology

Primary Location: SITE - Secchia Center - 15 Michigan St NE, Grand Rapids

About the Role

The Clinical Research Nurse is responsible for protocol coordination, including research participant recruitment, enrollment, implementation, and follow-up of research procedures. This role promotes good clinical practices in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for clinical trials and human subject protection. The Regulatory Clinical Research Nurse provides regulatory support and guidelines based on Federal Guidelines and ensures compliance with Regulatory guidelines and Beaumont policies (FDA, NIH, and HIPAA).

Responsibilities

• Participate in subject screening, recruitment, consenting, enrollment, monitoring of treatment, and follow-up procedures.
• Distribute and maintain accountability for study articles, including drugs.
• Document all study-related procedures, events, and case report forms or electronic data capture systems.
• Participate in monitoring audits/visits and handle data queries.
• Prepare for and participate in audits by sponsors and external regulators.
• Prepare and/or review complex regulatory documents such as IRB applications, Informed Consent and Authorization documents, complex Amendments, Progress Reports, Adverse Event/Unanticipated Problem Reports, and Protocol Deviations.
• Communicate effectively with the IRB, research participants, research team, principal investigators, sponsors, primary care providers, and ancillary staff to educate on protocol requirements, ensure protocol adherence, participant safety, and Regulatory compliance.
• Participate in pre-study preparation, including budget development, regulatory document preparation, and problem-solving.
• Monitor enrollment goals.
• Practice BH hospitality standards.
• Ensure and participate in appropriate collection, processing, and shipping of research specimens.
• Implement quality controls and assurance measures and maintain professional and technical knowledge.
• Protect research participant confidentiality.
• Engage in research participant/family interaction, utilizing effective communication skills and incorporating specific age, cultural, or developmental needs.

Qualifications

• Bachelor's Degree in nursing (Required).
• Current phlebotomy skills (Preferred).
• Prior medical/surgical clinical experience (Preferred).
• Registered Nurse (RN) - State of Michigan (Required upon hire).
• Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates (Required within 3 years).
• Clinical Research Professional, Certified (CCRP) - AACVPR American Association of Cardiovascular and Pulmonary Rehabilitation (Required within 3 years).
• CRT-IRB Professional, Certified (CIP) (Required within 3 years).
• Basic Life Support (BLS) - AHA American Heart Association (Preferred) or Basic Life Support (BLS) - ARC American Red Cross (Preferred).

Benefits

• Comprehensive benefits package to meet financial, health, and work/life balance goals.
• On-demand pay program powered by Payactiv.
• Discounts directory with deals on restaurants, phone plans, spas, and more.
• Optional identity theft protection, home, and auto insurance.
• Traditional and Roth retirement options with service contribution and match savings.

Schedule

• Employment Type: Full time
• Shift: Day (United States of America)
• Weekly Scheduled Hours: 40
• Hours of Work: 8:00 a.m. to 4:30 p.m.
• Days Worked: Monday to Friday
• Weekend Frequency: Variable weekends