CLINICAL RESEARCH GENETIC COUNSELOR

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.

Participate in or lead day-to-day operations of clinical research studies conducted by Principal Investigators within the Medical Genetics division; 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 clinical settings. 

This genetic counselor will join a research team dedicated to developing and deploying genomic technologies in the effort to diagnose severe childhood and adult disease through the Undiagnosed Diseases Network clinical site at Duke University Medical Center. He or she will help utilize various diagnostic tests/strategies including whole genome and whole exome sequencing across multiple therapeutic areas, and will help to establish and implement appropriate processes for genomic diagnostics. This job requires working knowledge of the application and limitations of various genomics technologies, and skills for annotating genetic variants and communicating results to patients. 

Work Performed 

Clinical Research Operations- 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 (SOP) 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. 

. Recognize the need for agreements (e.g. Material Transfer Agreements, Investigational New Drug Applications, etc.) 

2. Genetic Counselor activities. Plan, provide, supervise, and document professional genetic counselor care process for patients in accordance with physician orders and established policies and procedures. Use professional genetic counselor judgement when conducting genetic counselor research activities with patients. Examples of these include: 

Formulate and execute case management in collaboration with other team members and patient/family including appropriate referrals to other health care providers. 

Provide traditional genetic counseling services. 

Review and interpret genetic testing information to facilitate the development of an intervention/informational plan for the patient and his/her family. 

Review existing medical records and determine additional required information. Foster cross disciplinary relationships to promote research in the clinic population. 

Document follow up and ongoing care in EPIC. 

Participate in intellectual activities related to the research, including scientific results interpretation and contribution/leading manuscripts. 

3. Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed with conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security. 

Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation. 

4. Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Successful applicants should be familiar with clinical and research-based genomic technologies inclusive of genome sequencing and have familiarity with common tools used for variant annotation and interpretation.. They should have the ability to coordinate further functional studies or outreach projects to achieve or confirm a diagnosis. 

Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPS for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. 

Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerability related to security of data and data provenance. 

5. Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. 

6. Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. 

Assign, review, and train others in various work responsibilities. Serve as mentor to junior staff, genetic counselors and CRCs. Employ escalation and performance plans as needed.

Education
Master's degree or Ph.D. degree in Human Genetics or Genetic Counseling from an American Board of Genetics Counseling (ABGC) accredited training program and American Board of Medical Genetics (ABMG) or American Board of Genetic Counseling (ABGC) board certified. If the employee is not board certified, they must be actively pursuing board certification. Establish and maintain Genetic Counselor credentials through the Duke Credentials Verification Office.

Experience
One year of clinical experience as a board-eligible genetic counselor or genetic counselor intern.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position from USD $74,646.00 to USD $112,418.00. Duke University considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, and key skills, internal peer equity, as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

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.