Senior Clinical Research Nurse Coordinator
2 weeks ago
Duke University School of Medicine, established in 1930, is recognized as one of the premier medical schools in the United States, currently ranked sixth nationally. The institution prides itself on fostering an inclusive environment that encourages collaboration among exceptional learners, researchers, clinicians, and support staff. With a robust community of over 2,600 faculty members, nearly 2,000 students, and more than 6,200 staff, Duke Health represents a leading academic medical center, encompassing various hospitals and health services.
Position Overview
The Senior Clinical Research Nurse Coordinator plays a pivotal role in leading a clinical team dedicated to executing complex oncology clinical trials and research initiatives, particularly within the Duke Cancer Institute's Breast Clinical Research Program. The Oncology Clinical Research Unit is responsible for overseeing the integrity and compliance of research activities.
Key Responsibilities
Operations, Study, and Site Management - 20% Effort
- Implement strategies to enhance participant recruitment and retention, addressing individual participant needs. Evaluate study feasibility and retention strategies, identifying challenges and proposing solutions.
- Collaborate closely with the Principal Investigator and study team to facilitate participant enrollment and ensure informed consent is documented accurately.
- Coordinate study activities among direct reports to ensure successful study implementation. Identify study-related challenges and escalate issues as necessary.
- Ensure compliance with institutional policies and maintain accurate study documentation, including regulatory binders and enrollment logs. Oversee the reporting of adverse events and ensure proper training of personnel on study-specific duties.
- Lead the creation of Conflict of Interest, Data Safety Monitoring Plans, and Research Data Security Plans, coordinating with external monitoring boards.
- Manage study-related financial processes, including participant care expenses and budget development, ensuring accurate reporting of financial milestones.
Communication - 20% Effort
Act as a knowledgeable resource regarding research conduct, fostering collaboration and clear communication with study personnel. Address concerns professionally and respond promptly to inquiries.
Data Management - 10% Effort
- Identify and resolve issues related to data capture and management, ensuring data security and integrity.
- Review data entry for accuracy and completeness, implementing corrective measures as needed.
Leadership - 25% Effort
- Foster a team culture that promotes open communication and creativity. Ensure fair application of human resource policies and collaborate with HR on personnel matters.
- Supervise and manage assigned staff, overseeing their daily tasks, work schedules, and performance evaluations.
- Set clear performance goals for staff, facilitating their professional development and ensuring compliance with standard operating procedures.
- Serve as a resource for colleagues, supporting their project efforts and encouraging successful completion.
Ethics - 10% Effort
- Clarify professional guidelines and ethical standards for clinical research to study teams.
- Adhere to policies and regulations governing clinical research, maintaining required training and certification.
RN Responsibilities - 15% Effort
Operate within the professional scope of a licensed RN in the context of research, providing guidance and training to nursing staff as necessary.
Minimum Qualifications
Education: Graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program is required. Current RN licensure in North Carolina is mandatory.
Experience: A minimum of twelve months of relevant clinical experience, along with four years of research experience, is required.
Preferred Qualifications: Previous experience in oncology or clinical research is highly desirable.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to diversity and inclusion in the workplace. All members of the community are expected to uphold these values.
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