School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Lead day-to-day operations of multiple study teams conducting clinical research at Duke Health; perform a variety of complex duties involved in the collection, compilation, documentation, and analysis of clinical research data; lead others in navigating the clinical research environment. Lead or participate in a variety of unit, department, or division-level initiatives. Provide and document professional nursing care for research participants. Oversee the work of Clinical Research Coordinators (CRCs), Clinical Research Nurse Coordinators (CRNCs), and other research staff.

Work Performed

1. Clinical research operations. Provide oversight and training to team members who screen, schedule, consent, and collect adverse event information for participants in a variety of studies. Provide oversight and training to team members who maintain subject level documentation, including documentation in the electronic medical record. Serve as a resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Evaluate processes to identify issues related to recruitment and retention, and implement innovative solutions to maximize recruitment and retention.

Develop IRB documents and train other staff in these tasks. Train staff to maintain exemplary documentation, including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.

Design best methods for management of IP for drug, device, and biologic studies. Oversee implementation of, and compliance with, the required systems for IP for sponsored protocols. Serve as an expert resource for study teams, DUHS procurement, billing, and compliance for the proper handling of IP. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc.

Direct study teams compliance with appropriate collection of AE information per protocol, and provide input for adverse event reports. Serve as a resource to junior staff and the department or division with regard to institution and sponsor specific reporting requirements.

2. Ethical and participant safety considerations. Provide division or department wide

training in ethical conduct of research, and provide guidance in strategies used to maintain safety. Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

Serve as a resource to help staff and patients recognize the difference between clinical care and clinical management of research participants.

Independently develop documents related to safety and security. Serve as an expert resource for development and implementation of RDSPs, DSMPs, and Conflict of Interest plans across multiple studies or study teams.

3. Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Independently design CRFs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each.

Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Oversee the creation and use of queries, summaries, and reports. Develop system/framework for QA processes for multiple studies.

Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division.

Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities in data flow plans for multiple studies. May implement at unit level.

4. Scientific concepts and research design. Train others in the basic concepts of study design. Conduct and synthesize literature reviews, and independently develop proposals or protocols. Assess and determine solutions for operational shortcomings of proposals and protocols. Identify and collaborate with various stakeholders to ensure adequate design, implementation, and testing of study aims.

Summarize and interpret study results, and determine application to future study procedures.

5. Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Network and encourage leadership opportunities for staff within a small work group. Lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Independently lead scientific or programmatic presentations and publications.

6. Study and site management. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expensed route in a timely manner; troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Coordinate with financial teams, PRMO, etc. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets.

Coordinate operational plans for multiple research studies. Develop systems and documents including process flows, training manuals, and SOPs as appropriate with study teams.

Work with sponsors/study teams to arrange required training. Lead site initiation, monitoring, and closeout visits and activities; provide feedback to the study team members. Develop and implement closeout procedures for multiple studies.

Use system reports to ensure compliance with institutional requirements and other policies; assist team members with understanding these requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties.

7. Communication and team science. Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. 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.

8. Nursing activities. Plan, provide, supervise and document professional research nursing activities utilizing the nursing process for research subjects in accordance with physician orders and established policies and procedures. Use professional nursing judgment when conducting nursing research activities to patients.

Appropriately order sets following institutional and protocol guidelines.

Delegate tasks and supervise the activities of other licensed and unlicensed research staff.

Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources. Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.

Complete 18 hours of Continuing Education per year. Maintain compliance with required hospital and unit specific training competencies.

Work requires graduation from an accredited BSN or Associates 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. Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).

Twelve months of appropriate clinical experience is required, plus four years of research experience.

Skills: Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

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.

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 essentialjob 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.