Clinical Research Specialist, SR
Thoracic Clin Rsrch
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute’s (DCI) Oncology Clinical Research Unit (OncCRU) for the Thoracic Research Program. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.
Clinical Research Operations
Screen, schedule, conduct visits, and consent participants in minimal risk studies, including documentation of the consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Document visits, testing and interviews according to study protocol and Standard Operating Procedures (SOPs). Assist participants with individual needs.
Collect, prepare, process, ship, and maintain inventory of research specimens. Collect, prepare or process adverse event information under supervision. Provide input for adverse events reports. Assist with maintenance of study level documentation. Prepare for study monitoring or study audit visits.
Provide input for Institutional Review Board (IRB) documents such as consent forms, protocols, and continuing reviews.
Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.
Enter data accurately using Electronic Data Capture (EDC) systems, technologies, and other software. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Run summaries and reports on existing data. Use required processes, policies, and systems to ensure data security and data provenance.
Independently investigate incomplete, inaccurate, or missing data and documents to ensure accuracy and completeness of data; follow SOPs for data quality assurance. Recognize and report vulnerabilities related to security of physical and electronic data.
Encourage and support colleagues. Assist research colleagues in identifying efficiencies and improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
Maintain Duke and project specific training requirements.
Study and Site Management
Participate in sponsor-required training. Maintain inventory and quality of study supplies and equipment. Prepare items for site initiation visits, and take part in visits as directed.
Participate in study team meetings. Promptly respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.
And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
Requisition Number 401493217
Duke Entity MEDICAL CENTER
Job Code 803 CLINICAL RESEARCH SPECIALIST, SR
Job Family Level 09
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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.
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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.
Work requires an associates degree.
One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).
The preferred candidate will have oncology or research experience, training, education.
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