Clinical Research Specialist, Senior (Part-time)

Duke School of Nursing

• School of Nursing Established in 1931, Duke University School of Nursing is among the top-ranked nursing schools. The school is proud of its overarching commitment to educating the next generation of nurse leaders and advancing the role of nurses and nursing in the transformation of health care and in the expansion of health equity. The School of Nursing has an inclusive and diverse community that supports the professional goals of its students, faculty, and staff as they pursue excellence. Comprised of 1,600 faculty, staff, instructors, and students, the Duke University School of Nursing, Duke University School of Medicine, and Duke University Health System are a part of Duke Health. The Duke University Health System is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a network of health services. It encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Health Integrated Practices, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations
• Duke University Health System was awarded the American Board of Nursing Specialties Award for Nursing Certification Advocacy for being strong advocates of specialty nursing certification.
• Duke University Health System has 6000 + registered nurses
• Quality of Life: Living in the Triangle!
• Relocation Assistance!

The candidate selected must be fluent in speaking, reading, writing, and comprehending Chinese.

GRANT FUNDED

OCCUPATIONAL SUMMARY

This part time position includes chronic disease management and health promotion research funded by the National Institutes of Health (NIH). During the first phase of the study, this team member will be will be primarily working as an outcome assessor for patients in the study at Duke and various community settings in the RTP area of North Carolina, and will be blinded with regarding the allocation of enrolled participants into either the treatment or the controlled arm. This team member will collect data via surveys, and complete relevant study documentation in REDCap and Duke clinical management systems. In addition, this team member will work with the investigators to prepare manuscripts and scientific presentations. The job requires occasional travel around RTP area in North Carolina.

SUPERVISOR

This position reports to the SON Research Practice Manager with a dotted line to the PI.

WORK PERFORMED

1. Clinical Research Operations

• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).
• Collect outcome data and adverse events (AE) information for participants in a variety of noncomplex research studies.
• Maintains subject level documentation, including documentation of collected data in the REDCap.
• Prepare documents, equipment, or supplies for research visits.
• Conduct and documents visits and protocol-specific testing according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for noncomplex studies independently.
• Assist with prepare for study monitoring or study audit visits. Assist with addressing and correcting findings.
• May provide input for IRB documents. Collaborate to maintain appropriate study-level documentation.
• Collect, prepare, or process adverse event information per protocol, and provide input for adverse event reports. May complete and submit AE Reports, according to institution and sponsor-specific reporting requirements.

2. Ethical and Participant Safety Considerations

• Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
• May help with development and submission documentation and information for Institutional Review Board (IRB) review.

3. Data Management and Informatics

• Use REDCap and/or technologies, and software necessary for study operations. May score tests, enter data, and complete REDCap surveys according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data 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.
• 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.
• Assists in updating reports on study progress for the PI and other study team members and collaborators.

4. Scientific Concepts

• Assists with or contributes to the development of research protocols.
• Demonstrates a basic understanding of the elements of research study designs.
• Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.
• Assists with simple literature searches.
• Serve as an author on poster presentations or publications.

5. Study and Site Management

• Records basic protocol information in clinical research management system.
• Ensure that studies are conducted in compliance with institutional requirements and other policies.
• Follows, and may develop or implement, protocol specific systems and documents including process flows.
• Uses REDCap systems and systems reports to manage research participants activities and charge routing.
• As directed, assists in preparing studies for closeout and document storage.

6. Leadership and Professionalism

• Proactively seeks opportunities to add relevant skills and certifications to own portfolio.
• Keeps current with research updates by attending key external offerings (i.e., Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job.
• May disseminate information to others.
• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• Demonstrates resilience and is adaptive to change.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

7. Communication and Team Science

• Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements.
• Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

DEPARTMENTAL PREFERENCES

Education/Training

1. Completion of a Bachelor's degree
2. Completion of an Associate’s degree plus a minimum of two (2) years relevant experience (e.g., research, clinical, interaction with study population, program coordination)

Experience

Experience in research study preferred

SKILLS

• Can easily use computing software and web-based applications (e.g., Microsoft Office products, REDCap, and internet browsers).
• Can communicate fluently in Chinese is required.

MINIMUM QUALIFICATIONS

Anticipated Pay Range

Duke University provides an annual base salary range for this position as USD $ 20.35 to USD $30.82. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizationalconsiderations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members.

Learn more at: https: //hr.duke.edu/benefits/

Education

Work requires an Associate's degree.

Experience

One year of relevant experience. A Bachelor's degree may substitute for required experience.

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 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.