Clinical Research Nurse Coordinator-Duke Early Phase Research Unit
DUKE EARLY PHASE RESEARCH UNIT
Occupational Summary:Develop, coordinate and supervise research and administrative activities of clinical research studies conducted by the Duke Early Phase Clinical Research Unit(DEPRU); develop and over see a variety of complex activities involved in the collection,compilation, documentation and analysis of clinical research data.
Independently plan and provide professional nursing care for patients/subjects in accordance with physician orders, established policies and procedures and the research protocol. Provide nursing care services in accordance with the scope of the RN as defined by the North Carolina Board of Nursing.
- Clinical research operations. Screen, schedule, consent, and collect adverse events(AE) 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. May provide training to personnel.Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks; improve systems related to specimen handling.Prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.Develop or provide input for IRB documents. Maintain, or collaborate to maintain, appropriate study-level documentation.Assist with management of Investigational Products (IP). Employ the required system for handling,dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols,or coordinating with investigational pharmacies as necessary. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level.Collect, prepare, or process adverse event information per protocol,and provide input for adverseevent reports. May complete and submit AE Reports, according to institution and sponsor-specific reporting requirements.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. Recognize the need for agreements (e.g.,Material Transfer Agreements,Investigational New Drug Applications, etc.).
- Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research.Train junior staff in theethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.May develop, or assist with the development of, documents related tosafety and security.Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.
- Data management and informatics. Use and train others in Electronic Data Capture(EDC) systems, technologies, and software necessary for studyoperations. Score tests, enterdata, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments.Detect issues related todata capture, collection or management; suggest solutions.Investigate incomplete, inaccurate, or missing data/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.May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate.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. Predict areas of vulnerability for a flow plan.Determine areas where data provenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements are necessary; may assemble the necessary parties to ensure that all agreements are in place.
- Scientific concepts andresearch design. Understand and train others in 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.Identify various stakeholders (statistical, operational, etc.) toensure adequate design,implementation, and testing of study aims. May determine operational/statistical elements neededfor conduct of clinical and translational studies.
- Leadership and professionalism. Assist research colleagues inidentifying efficiencies and improving process. Successfully take part in or lead a committee ortask force. Actively seekout 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 CRCs. Employ escalation and performance plans asneeded.Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May beresponsible for identifyingpotential problems and risks to the participants, study, and institution.
- Study and site management. Participate in sponsor-required training.Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist with studybudgets.Prepare for, take part in, and potentially lead site initiation,monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retentionstrategies. May make recommendations to investigators and over sightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.
- Communication and team science.
Requisition Number 401468421
Duke Entity MEDICAL CENTER
Job Code 1203 CLINICAL RESEARCH NURSE COORDINATOR
Job Family Level 54
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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 twoyears of their start date and to complete the program within five yearsof their start date.Must have current or compact RN licensure in the state of NorthCarolina. BLS required.
Twelve months of appropriate clinical nursing experience is required.
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
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Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
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