Clinical Research Nurse Coordinator

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Provide leadership for a clinical team that conducts multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Bone Marrow Transplant, Hematology Malignancies & Cellular Therapy Clinical Research Programs [BMT]. The Oncology Clinical Research Unit [CRU] oversees the conduct of research.

Work Preformed

Operations 30% Effort

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. Screens participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts activities for study visits in compliance with the protocol. Participates in study team meetings. May train or oversee others.

Study and Site Management 30% Effort

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. 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. 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. May forecast effort needs. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may 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.

Communication 15%

Serve as an expert resource on the conduct of research. Collaborate, and communicate with study personnel as required. Communicate concerns clearly in a professional manner. Respond timely to emails, phone calls and questions. Escalate issues to others as appropriate.

Data 10%

Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols. Innovatively uses technology to enhance a research process. May train others. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.

Leadership 5%

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. 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 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.

Ethics 10%

Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

RN Responsibilities

Operate within the scope of the professional capacity of a licensed RN as it relates to research. Provide direction and training to RN staff as needed.

Science
Demonstrates a basic understanding of the elements of research study designs.

Clinical Responsibilities
• Ambulatory Medication Administration
• Adult Medication
• Adult Chemotherapy Administration
• Basic Dysrhythmia Review

Type of Research
This position is for a research nurse coordinator for the Multiple Myeloma team.

Other work as assigned. 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.

Minimum requirements

Education

Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelors 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. The preferred candidate will have oncology or research experience.

Job Code: 00001203 CLINICAL RESEARCH NURSE COORDINATOR
Job Level: 54

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