CTSI Clinical Research Genetic Counselor (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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care 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.

 

Occupational Summary

Participate in or lead day-to-day operations of a large clinical research study conducted by a principal investigator in the Duke Clinical & Translational Science Institute; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and students (post-doctoral, graduate, and undergraduate). This position also encompasses skills and knowledge required of a certified genetic counselor with activities that may occur in research and may impact clinical settings.

 

Work Performed

1. Clinical research operations

Return genetic sequencing results to study participants. May potentially mentor students who are either interested in or pursuing a genetic counselor degree. May assist with recruitment and/or sample collection

 

Establish and execute return of results workflows as approved by the Steering Committees as part of the protocol for the study, via the tasks below, required for the Clinical Research Genetic Counselor.

 

Screen, schedule, consent, and collect adverse events (AE) information for participants in a variety of studies. Maintain subject level documentation, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. May provide training to personnel.

 

Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling.

 

Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.

 

Develop or provide input for IRB documents. Maintain, or collaborate to maintain, appropriate study-level documentation.

 

Assist with management of Investigational Products (IP). E