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CLINICAL RESEARCH GENETIC COUNSELOR
Job Title: CLINICAL RESEARCH GENETIC COUNSELOR
Job Code: 1054
Job Level: 81
Revised Date: 08/01/2022
Job Family: JF 10
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. 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.
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 (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).
Employ the required system for handling, dispensing and documentation of IP for sponsored protocols.
May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary.
Maintain appropriate documentation.
Track IP compliance at the protocol-and subject level.
Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
May complete and submit AE.
Reports, according to institution and sponsor-specific reporting requirements.
Have familiarity with intellectual property rights, inventions patents, and technologies.
As appropriate, understand regulations related to investigational products with sponsors.
Coordinate with Duke Core services.
Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.)
Ethical and participant safety considerations.
Maintain familiarity with the ethical conduct of research and safeguards needed when 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.
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.
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 vulnerabilities related to security of data and data provenance.
Map protocol data flow.
Predict areas of vulnerability for a protocols data flow plan.
Determine areas where data provenance may be compromised and develop solutions.
Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place.
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.
Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.
May determine operational/statistical elements needed for conduct of clinical and translational studies.
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 a mentor to junior staff, including other CRCs.
Employ escalation and performance plans as needed.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams.
May be responsible for identifying potential problems and risks to the participants, study, and institution.
Study and site management.
Participate in sponsor-required training.
Obtain information for or coordinate operational plans for multiple research studies.
Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs.
Ensure participant care expenses have appropriate financial routing.
Monitor financial study milestones and report appropriately.
Coordinate with financial teams, PRMO, etc.
Assist with study budgets.
Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities.
Collect information to determine feasibility, recruitment and retention strategies.
May make recommendations to investigators and oversight organization(s).
Maintain compliance with institutional requirements and policies.
Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.
Communication and team science.
Prepare for and lead team meetings.
Take an active role in including others in decision-making, and escalate issues appropriately.
Communicate with sponsors, subcontractors, or vendors.
May be responsible for taking action when communication has stalled with sites, CROs, sponsors.
Maintain Duke and project specific training requirements.
Develop solutions to proactively ensure study team members compliance with training requirements.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.
Make recommendations to investigative team.
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.
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 judgment when conducting genetic counselor research activities with patients. Examples of these activities 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. <
Required Qualifications at this Level
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, he/she must be actively pursuing board certification. Establish and Maintain Genetic Counselor credentials through the Duke Credentials Verification Office.
One year of clinical experience as a board eligible genetic counselor or genetic counselor intern.
Strong Interpersonal skills and psychological counseling skills. Ability to learn research protocols and adhere to federal, state, and institutional rules and regulations related to the ethical conduct of research. Ability to work in a complex, work environment. Intellectual curiosity and motivation to pursue research questions. Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University 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 essential job 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.