Clinical Research Nurse Coordinator, Department of Neurosurgery
Participate in or lead day-to-day operations of clinical research studies conducted by principal investigator(s) of the Ortho/Neuro Spine Division 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. Perform all study activities following clinical practices. Manage multiple clinical trials with increasing complexity simultaneously.
Trials may be complex in nature and may involve management of multiple sites.
- Protect the safety of human subjects.
- Assure all tests required by the study are executed.
- Obtain informed consent from Human Subjects.
- Obtain all data required for each study.
- Monitor patient compliance. Obtain records and submit data to appropriate parties.
- Monitor appropriate sources for specific clinical study or federal regulation updates.
- Facilitate audits of study data.
- Develop patient rapport in order to explain research protocols and minimize protocol violations.
- Develop rapport with study team to educate team on study procedures and minimize protocol violations
- Serve as back up CRC for other Neurosurgery studies with increasing complexity.
- Coordinate and attend site evaluation and initiation meetings.
- Navigate study start-up and procedure planning for operating room trials with designated clinical teams.
- Advertise, recruit and screen patients for studies.
- Coordinate and attend the study close-out visit.
- Finalize all patient record entries
- Finalize study material accountability and study files
- Properly store and file study files In collaboration with NSU RPM supervise team members, including mentoring and providing resources to them as needed.
- Function as lead spine CRC, help with training new team members involved in this specialty.
- Assist with hiring process for new employees within Spine team.
- Assist PI in developing clinical trial protocols, and submit the required documentation to the IRB, the University, and sponsors.
- Maintain proper protocol, consent, amendment and yearly renewal submission. Report adverse events. Maintain study files.
Preferences: At least 2 years clinical research experience preferred.
Requisition Number 401478502
Duke Entity MEDICAL CENTER
Job Code 1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level 54
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.
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.
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