Clinical Research Analyst, Operations

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.

Duke University Job Description

Job Title: Clinical Research Analyst, Operations

Support the research community’s use of research applications, including Advarra OnCore (clinical research management system) and Advarra eReg (electronic regulatory binder). Maintain an understanding of research workflows and advise end users on requirements and best practices for utilizing research systems. Collaborate with internal and external stakeholders to improve system performance, streamline workflows, and maintain training materials.

Administrative support for research systems

• Demonstrate an understanding of institutional approval requirements. Review protocols and issue Institutional Approval in OnCore.
• Review reports and error logs on a regular basis to identify and address issues with the flow of information between research systems (e.g. iRIS, OnCore, Maestro Care). Monitor data entered into research systems for compliance with institutional policies and procedures.
• Support activities to maintain Part 11 compliance for the eReg application.
• Attend stakeholder meetings for supported applications.

End user support for research systems

• Demonstrate a clear understanding of OnCore and eReg functionality. Support end users with workflows related to management of protocol and participant information.
• Help end users understand institutional policies and procedures for supported applications.
• Monitor the assigned Service Now queue to triage and address support requests in a timely manner.
• Independently troubleshoot issues reported by end users.

Education, training, and communication

• Maintain and update training materials. Create end-user communications related to system updates, new resources, and changes in workflows.
• Collaborate with stakeholders external to DOCR to support system upgrades and resolve issues.
• Participate in educational presentations and in-services as needed.

Education/Training: Work requires one of the following:

Work requires graduation from an accredited degree program in a clinical field such as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years clinical and/or research experience; or

2. Completion of a bachelor's degree in a field related to health science and a minimum of three clinical and/or research experience.

Experience:

None required beyond that described above

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills: N/A

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.