Clinical Research Nurse Coordinator
Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. 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 Conduct and document consent for participants in a variety of studies independently and provide training to others in these tasks. Assist with addressing and correcting findings from study monitoring and study audit visits. Oversee the collection of adverse event information Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently.
Recognize when patients are having difficulties with this distinction. 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 of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial
Use EDC systems and enter data accurately and train others in these tasks. Detect issues related to data capture, collection or management and suggest solutions. Use required processes, policies, and systems to ensure data security and provenance. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Follow SOPs for data QA.
Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed. 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:
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. Assist with study budgets. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Lead site initiation activities Recognize components of operational plans and be able to obtain information needed to develop the plan. Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities
Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members. Take an active role in including others in decision-making.
Description of Portfolio and Clinical Responsibilities:
- Adult Medication
- OR Medication
- Alaris Pump Set up and Use
- Draw blood from arterial lines
Type of Research
This position is in the Anesthesiology CRU and will work with a variety of patient populations and in a variety of clinical settings.
Requisition Number: 401511245
Duke Entity: MEDICAL CENTER
Job Code: 1203 CLINICAL RESEARCH NURSE COORDINATO
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.
Auto req: ID106330BR