Clinical Research Specialist Senior

1 month ago

Durham, North Carolina, United States Duke University Full time
Job Summary

As a Clinical Research Specialist Senior at Duke University, you will play a vital role in supporting the conduct of clinical research for the Duke Cancer Institute's GU HUB Clinical Research Program. You will be responsible for performing a variety of research, data, and clerical duties of a routine and technical nature to ensure the success of our research initiatives.

Key Responsibilities

• Screen participants, conduct and document consent for participants in minimal risk studies, and maintain subject-level documentation.
• Schedule participants for study visits, prepare necessary documents, equipment, supplies, and interviews according to study protocol and Standard Operating Procedures (SOPs).
• Collect, prepare, process, ship, and maintain inventory of research specimens.
• Perform a variety of technical duties involved in conducting physical, chemical, or biological tests, experiments, and determinations to obtain data in support of research-oriented activities.
• Compile and document procedures and results, and maintain sufficient inventory of materials, supplies, and equipment for performance of duties.
• Review work of lower-level laboratory personnel and assist in the training of new personnel.
• Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.
• Use Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study data, and complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
• Follow SOPs for data QA, and use required processes, policies, and systems to ensure data security and provenance.
• Recognize and report vulnerabilities related to security of physical and electronic data.
• Actively network, participate in team meetings, committees, task forces, and ad hoc groups, and encourage career development by actively seeking out continuing education opportunities.
• Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research, and be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations.
• Maintain Duke and project-specific training and certification requirements.

Requirements

• Associate's degree; Bachelor's degree preferred.
• One year of relevant experience; a Bachelor's degree may substitute for required experience.
• Basic Life Saving (BLS) certification from the American Heart Association or Duke-approved equivalent course is a requirement of this position.

About Duke University

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.

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