May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary. Maintain, or collaborate to maintain, appropriate study-level documentation.Īssist with management of Investigational Products (IP).Įmploy the required system for handling, dispensing and documentation of IP for sponsored protocols. Prepare for study monitoring or study audit visits.Īssist with addressing and correcting findings.ĭevelop or provide input for IRB documents. May provide training to personnel.Ĭollect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks improve systems related to specimen handling. Prepare documents, equipment, or supplies for research visits.Ĭonduct 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.Įmploy strategies to maintain recruitment and retention rates, and to assist participants with individual needs.Įvaluate processes to identify issues related to recruitment and retention rates. Maintain subject level documentation, including documentation of consent in the electronic medical record. Screen, schedule, consent, and collect adverse events (AE) information for participants in a variety of studies. This position also encompasses skills and knowledge required of a certified genetic counselor with activities that may occur in research and clinical settings. May oversee the work of junior staff and students (post-doctoral, graduate, and undergraduate). Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. Job Title: CLINICAL RESEARCH GENETIC COUNSELOR Genetic counselors have an important role in the evaluation of families at risk of BAV.CLINICAL RESEARCH GENETIC COUNSELOR (1054) The list of associated genes is constantly growing. Identifying cases of BAV with an identifiable genetic cause can significantly impact patients and family members. Genetic testing can reduce morbidity and mortality by guiding management strategies and identifying asymptomatic relatives before significant complications occur. Genotype-phenotype correlations exist that impact treatment recommendations. There is wide phenotypic variability among BAV malformations, including which cusps are involved and the degree of aortic root involvement.
There is high heritability associated with BAV, and several specific genes have recently been associated with BAV. Individuals with BAV are at significantly increased risk of progressive aortic valve disease and aortic root aneurysms. This article discusses potential genetic causes of BAV, includes a list of current known and candidate genes associated with BAV, provides a hypothetical case demonstrating the importance of genetic testing and cascade screening, and highlights the value of genetic counselors specializing in cardiovascular genetics. BAV may occur as an isolated finding or as a feature of certain syndromes. Bicuspid aortic valve (BAV) is a common congenital heart defect, with an estimated frequency of 1-2% in the general population.
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