Duke University Hospital

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at Duke University Hospital

Posted: 9/16/2019
Job Reference #: 1367635

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Duke Entity

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Job Description
Screen participants for all studies and  maintain subject level documentation for all studies independently. Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP.  Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Implement innovative solutions to maximize recruitment and retention. Independently conducts and documents consent for participants in all studies, including those that are complex in nature/clinically relevant and/or require access to the EHR for documentation.  Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. 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 such as Investigational Drug Service (IDS), Biobank, etc.  Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Recognize when patients are having difficulties with the distinction between clinical care and research. Make recommendations regarding how to improve communications to help patients and staff understand the distinction. Be familiar 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. Assist with the development Research Data Security Plans (RDSPs). 
Use Electronic Data Capturesystems, technologies, and software necessary for study operations.  Enter data accurately.  Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms accurately and according to protocol. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Assist with development of and follow SOPs for data quality assurance. Recognize when data agreements are necessary.

Study and Site Management:
Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately.  Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate.  Maintain study's compliance with institutional requirements and other policies. Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.
Communicate concerns clearly and in a professional manner. Participate in study team meetings. 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.
Type of Research
This position will be managing a clinical trial in the geriatric population in the setting of multiple nursing homes. The focus will be education to prevent falls and managing medications. Contact with the site will be mostly remote, but there will be occasional visits to the sites. 


Requisition Number

Position Title


Job Family Level

Full Time / Part Time

Regular / Temporary

Department Name
Medicine - Geriatrics

Minimum Qualifications
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.


Work requires graduation from an accredited BSN or Associate's Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.


Twelve months of appropriate clinical nursing experience is required.
Special Skills
The ideal candidate would have experience in the geriatric population and be comfortable with educating other providers. Organizational skills and some prior experience in clinical research will be imperative for managing the study.