School of Nursing:

Established in 1931, Duke University School of Nursing is among the top ranked of the nation’s nursing schools. The School is proud of its overarching commitment to transform the future of nursing to advance health in individuals, families and communities. Members of the School of Nursing are part of an inclusive community that supports the professional goals of its people as they pursue excellence.

Comprised of 1,600 faculty, staff,instructors and students, the Duke University School of Nursing along with the Duke University School of Medicine 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.

Duke University School of Nursing
Job Description
HR Job Title: Clinical Research Coordinator
Job Code: 1202
Job Level: 53
Updated: 07/06/2021

Occupational Summary
The Hu lab is active in developing advance AI/machine learning based digital health solutions to improve patient monitoring and clinical decision support across different patient care areas from acute care to ambulatory settings. With regard to regulatory and strategic aspects related to the lab, this senior clinical study coordinator position will assist PI develop, coordinate, implement, monitor, and iterate administrative strategies essential to the mission of the lab. The position will assist PI in a variety of multifaceted duties involved in supporting tasks related to the regulatory, licensing, and compliance issues. The person will coordinate the team in problem solving regulatory and compliance issues of moderate to complex scope. Coordinate communication and operational efforts between all relevant stakeholders including the School of Nursing Center for Nursing Research, Business Office, Information Technology Office, other SON leaders and relevant Duke University central offices and schools to ensure successful operation of these programs. With regard to clinical studies, this senior clinical study coordinator position will support various clinical studies of algorithms and software solutions that are developed at the lab, closely work with the researchers in the lab and clinical collaborators in health systems including Duke and other institutions to recruit patients, collect physiological data, conduct chart review, and contribute to data analysis and reporting with opportunities to co-author publications and develop grant proposals.

This position may require occasional night or weekend work.

Supervisor
This position reports to the Research Practice Manager for the School of Nursing with a dotted line to the study Principal Investigator.

Work Performed
Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing. Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. For multiple study teams, develops and oversees the implementation of strategies for meeting recruitment goals. Provides training. Serves as an expert to research program team members in the area of screening. May provide oversight and conduct training in this area. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans. Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies.

Ethics:
Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information. Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May serve as an expert resource with regard to conducting and documenting consent including liaising with and being knowledgeable about other resources at Duke. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies. Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

Data:
For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol. Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. Recognizes trends and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.

Science:
Assists with or contributes to the development of funding proposals. Independently conducts literature searches and reviews. Independently develops protocols for complex investigator-initiated studies, across multiple PIs or study teams. Uses expertise in research design to provide significant contribution to protocols or research proposals. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications.

Study and Site Management:
Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. May train others. Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Oversees implementation of operational plans across multiple study teams or sites. Develops and implements closeout procedures for multiple studies across multiple teams.

Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.). Plays key role on committees and workgroups. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Develops and implements solutions that work within the existing leadership or organizational structure. Actively facilitates and leads multiple study team's adoption of change in their working environment. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.

Required Qualifications at this Level
Education/Training
Work requires an Associate’s degree

Experience
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience. Experience in research study and grant management preferred.

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

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.