RN Clinical Research Pediatric Oncology

Pediatric Oncology Clinical Research Nurse

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

Responsibilities include:

• Participate in subject screening, recruitment, consenting, enrollment, monitoring of treatment, and follow-up procedures.
• Distribute study article, including drug.
• Maintain study article accountability.
• Document all study-related procedures/events and documents, including 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, and to 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.
• Research participant/family interaction, utilize effective communication skills, incorporate specific age, cultural, or development needs.

Qualifications

• Required Bachelor's Degree in nursing.
• Required Registered Nurse (RN) - State of Michigan Upon Hire
• Required Prior medical/surgical clinical experience.
• Clinical Research Professional, Certified (CCRP) - SOCRA Society of Clinical Research Associates 3 Yrs required Or
• Clinical Research Professional, Certified (CCRP) - AACVPR American Association of Cardiovascular and Pulmonary Rehabilitation 3 Yrs required
• CRT-IRB Professional, Certified (CIP) - 3 Yrs required
• Basic Life Support (BLS) - AHA American Heart Association preferred Or
• Basic Life Support (BLS) - ARC American Red Cross preferred