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CLINICAL RESEARCH NURSE COORDINATOR - Radiation Oncology

Requisition Number::  170920
Date:  May 16, 2022
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Clinical Research Nurse Coordinator

Location: Radiation Oncology, Duke Cancer Center Clinic-00-01

Hours: Full-time (40hrs/wk), Monday-Friday

 

Operations:

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. Employs strategies to maintain retention rates. Evaluates 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. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts and plans for complex study visits. Leads meetings that are multidisciplinary, including those with complex objectives. This position may involve training and oversight of others.

 

Ethics:

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. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. This position may involve training and oversight of others.

 

Data:

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 RDSPs for multiple study protocols. Independently uses and implements technology to enhance productivity or process. This position may involve training and oversight of others.

 

Science:

Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship). 

 

Study and Site

 

Management:

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. Records basic protocol information in clinical research management system. For studies with complex supplies or equipment, ensures that there are ample supplies, and that equipment is in good working order. May forecast staffing needs. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. Prepares studies for closeout and document storage. This position may involve training and oversight of others.

 

Leadership:

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. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. 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. 

 

Type of Research:

Radiation Oncology has a portfolio of studies from Phase I-III, across all disease sites in oncology. Studies involve investigational agents, chemo-radiation and limited device studies, mostly single site studies with some multi -site studies.

 

Education

Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a bachelor’s degree in nursing, (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five 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).

 

Special Skills:

Ideally the successful candidate will have oncology and/or research experience. The successful candidate must have excellent communication and writing skills. The position demands a commitment to providing a high standard of care, to be flexible and adaptable to changes within the work environment on a regular basis, must be detail oriented, a critical thinker and be able to engage positively within a team dedicated to oncology research. Can easily use computing software and web-based applications (Microsoft Office products, EPIC, OnCore and IMedris and internet browsers). A minimum of 24 months of appropriate clinical nursing experience is required. BLS required. Maintain compliance with required hospital, Department and research specific training competencies as well as an active RN status and current license with the North Carolina Board of Nursing (NCBON).

 

Minimum Qualifications

 

 

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) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five 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).

 

Experience

 

Twelve months of appropriate clinical nursing experience is required.

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

 


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