Clinical Research Nurse Coordinator
This is a 100% sponsored funded position.
- Participate in clinical research studies conducted by principal investigators (PIs) for the Duke Cancer Institute’s (DCI) Oncology Clinical Research Unit (OncCRU) for the Adult Bone Marrow Transplant and Hematologic Team.
- Perform a variety of duties related to the implementation of clinical research protocols, including but not limited to, collection, compilation, documentation, and analysis of clinical research data; and the coordination of research studies.
- Screen, schedule, consent, and collect adverse event information for participants in a variety of studies.
- Maintain subject level documentation, including documentation of consent in the electronic medical record.
- Prepare documents, equipment, or supplies for research visits.
- Conduct and document visits and protocol- specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for all types of studies independently. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.
- Evaluate processes to identify issues related to recruitment and retention rates.
- Develop or provide input for Institutional Review Board documents such as consent forms, protocols, and continuing reviews in a timely fashion. Maintain or collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc.
- Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports.
- Maintain familiarity 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.
- Communicate to research participants, both orally and written, the difference between clinical activities and research activities, and the risks and benefits of study participation, in all study documents and research participant communications.
- Use and train others in Electronic Data Capture (EDC) systems, 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 (CRFs and eCRFs) accurately and according to protocol. Assist with the development of data collection documents to standardize process. Detect issues related to data capture, collection or management; suggest solutions.
- Investigate incomplete, inaccurate, or missing data or documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data.
- Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance.
- Map protocol data flow and predict areas of vulnerability. Determine areas where data provenance may be compromised. .
- Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place (e.g., data use agreements, data transfer agreements, Investigational Device Exemptions (IDEs), etc.).
- Understand the basic concepts of study design. Independently conduct literature reviews. Assist with the development of or develop proposals or protocols; identify shortcomings of proposals and protocols.
- Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Actively network and encourage leadership for staff within a small work group. Successfully take part in or lead a committee, task force, or ad hoc group. Encourage career development by actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications.
- Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other Clinical Research Coordinators. Employ escalation and performance plans as needed.
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
- Study and Site Management– Participate in sponsor-required training. Obtain information to coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents as assigned.
- Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Assist with study budgets.
- Prepare for, take part in, and lead site initiation, monitoring, and closeout visits and document storage activities as assigned.
- Collect information to determine feasibility, recruitment and retention strategies.
- Maintain study's compliance with institutional requirements, policies and standards.
- Actively participate in team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members.
- Communicate frequently with all other parties involved with research studies to effectively coordinate and advance the study.
- Operate within the scope of the professional capacity of a licensed RN as it relates to research.
- Other work as assigned.
- The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Requisition Number: 401517045
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.
- Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
- The preferred candidate will have oncology or research experience, training, education.
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