CTSI Clinical Research Nurse Coordinator (CPH)

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.

Organizational Summary

The Duke Clinical & Translational Science Institute (CTSI) is a Duke University cross institutional infrastructure resource that facilitates and fosters successful clinical and translational research through integration of programmatic research areas and resources across campus. CTSI is housed in the Duke School of Medicine (SOM) and has dual reporting to the Dean of the School of Medicine and the Chancellor for Health Affairs. It is the institutional home for the Clinical and Translational Science Award (CTSA), funded by the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH).  The CTSA is an institutional grant that provides infrastructure resources and career development opportunities to translational research teams at Duke. The CTSA encompasses 15 Cores, which provide specific resources, services, and training programs.

In addition to CTSA grant funded activities, the CTSI is comprised of a number of educational, service, and research programs and centers that focus on key strategic areas related to Duke Health translational science priorities.  The CTSI brings together stakeholders from all parts of the University and Health System and facilitates their work toward reaching the Chancellor’s strategic goals to achieve optimum science translation in clinical settings and in the community. CTSI also contributes to and promotes Duke University’s national visibility as a premier clinical and translational science academic research institution.

The Duke CTSI is the home for the Duke Center for Precision Health.  This Center will be the flagship structure for translational discovery and precision medicine within the Duke School of Medicine. The Center will be a nexus of human genomic and biomarker discovery, population genomics, genomics ethics and implementation science, all in support of precision health integrating the Duke School of Medicine with the Duke Health System.  The Center will leverage the SOM enabling infrastructure to support science including biobanking (OneDukeBio), SOM molecular omics cores (GCB sequencing, GCB proteomics, DMPI metabolomics, DMPI molecular genomics), health care informatics (DIHI, AI.Health), genomic computing (OIT/DHTS) and the DCRI (trial biorepository discovery, clinical translation trials).

Occupational Summary

Participate in or lead day-to-day operations of a large clinical research study conducted by a principal investigator in the Center for Precision Health. Perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data and samples. May oversee the work of junior staff and train or mentor others in clinical research tasks Provide and document professional nursing care for research participants.  Position will involve performing phlebotomy, walking between clinics and campus locations, processing samples, and flexible working hours (early start or late stop). Experience performing phlebotomy including from IV lines is required; fluency in Spanish is preferred.

Work Performed

1. Nursing activities.

Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients. May delegate tasks and supervise the activities of other licensed and unlicensed research staff. Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.

2. Research Operations.

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs). Screen participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems. Escalates issues. Conducts and plans for visits for complex studies (e.g., procedural and interventional studies). Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access to the Duke electronic health record (EHR). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.

3. Safety and Ethics.

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 Institutional Review Board (IRB) review. Communicates with the IRB staff and reviewers and handle issues appropriately. Identifies all adverse events (AEs), and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.

4. Data.

Enters and collects data, and 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. 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. Independently uses and implements technology to enhance productivity or process.

5. Scientific Concepts.

Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.

6. Site and Study Management.

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 for, coordinates, and actively participates in site visits. 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. Uses systems and system reports to manage research participants activities and charge routing. Prepares studies for closeout and document storage.

7. Leadership and professionalism.

May train or oversee others in the above tasks. 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. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Required Qualifications at this Level

Education/Training:

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.

Skills:

Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

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.