Clinical Research Nurse Coordinator

Be You.

Provide leadership and coordination in the conduct of multiple, complex oncology clinical trials and research studies including Investigational Products [IP] within the Lymphoma Clinical Research Team (CRT) as part of the Hematology Malignancies & Cellular Therapy Clinical Research Program [HMCT] within the Duke Cancer Institute’s [DCI] Oncology Clinical Research Unit [CRU]. 

Minimum Qualifications

Education

Work requires graduation from an accredited BSN or an Associate Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required. Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON). Exception: Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.

Experience

Twelve months of appropriate clinical nursing experience is required.

Preferences

The preferred candidate will have oncology or research experience. 

Be Bold.

Key Responsibilities

Operations, Study and Site Management – 30% Effort

Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. Maintains participant level documentation for all assigned studies, including those that are complex in nature (e.g., therapeutic and interventional studies) and/or require access to the Duke EHR. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Screens participants for complex studies (e.g., procedural and interventional studies). Escalates issues appropriately as needed.

Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and potentially develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. Prepares studies for closeout and document storage.

Knowledgeable in regulatory and institutional policies and processes; applies them appropriately in study documentation and SOPs. May train others in these policies and processes. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts activities or study visits in compliance with the protocol. Participates in study team meetings.

Develops or helps develop SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

Communication – 15% Effort

Serves as primary liaison with sponsors, study personnel and PI for assigned studies.  Collaborates with other study and clinical personnel as required.  Communicates concerns clearly in a professional manner.  Responds emails, phone calls and questions in a timely fashion.  Refers more complex questions and escalate issues to others as appropriate.  

Data – 5% Effort

Uses Clinical Trial Management System for study- and subject-level management and enters data accurately. As needed, uses Electronic Data Capture [EDC] systems and enters data accurately.  Detects issues related to data capture, collection or management and suggest solutions. 

Complies with required processes, policies, and systems to ensure data security and provenance.  Recognizes and reports vulnerabilities related to security of physical and electronic data.  Assists in investigating incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data. 

Leadership – 5% Effort

Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Develops and implements solutions that work within the existing leadership or out-patient organizational structure. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Serves on committees and workgroups internal to Duke or externally in therapeutic area of research.

Ethics – 5% Effort

Communicates to study staff and research participants the difference between clinical and research activities, and the risks and benefits of study participations.  Recognizes when staff and patients are having difficulty with the distinction and work hard to help them understand the differences. 

Summarizes and clarifies for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. 

Knows and follows policies, standard operating procedures [SOPs], regulations and protocol requirements that govern clinical research.  Maintains Duke and project specific training and certification requirements.

RN Responsibilities – 40% Effort

• Ambulatory Medication Administration
• Medication management to include patient education on specific study medications and side effects
• Adult Chemotherapy Administration
• Basic Dysrhythmia Review
• Review clinical laboratory results
• Assess patient to recognize adverse events, check patient compliance, provide education and appropriate interventions as guided by Principal Investigator [PI]. 
• Interact effectively with medical team.

Other work as assigned. 

Choose Duke.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.