REGULATORY COORD

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

The research programs housed within the Duke Department of Population Health Sciences explore factors that influence health and work to improve health at the population level by reducing disparities, measuring health needs, and implementing health innovations. Within DPHS, the DataShare™ serves as a designated shared resource, facilitating research access to health data from multiple sources coupled with regulatory, informatics, and biostatistics expertise in the use of this data. We are hiring a Regulatory Coordinator to support both DP HS and the DataShare™ to facilitate community-based research by helping to navigate the contractual and regulatory needs for multiple research initiatives within the Department. In addition, this role will assist with developing and maintaining Data Use Agreements for the use of large datasets (e.g., Medicare and Medicaid claims) in research, and maintaining regulatory and governance records for these data assets.

This position requires:

·        Familiarity with Duke clinical research management systems, including iRIS and OnCore

·        Knowledge of, and experience with, Duke institutional policies and processes regarding clinical research, setting up contracts with independent contractors and vendors, institutional reliance agreements, and data privacy and protection

Preferred:

·        Ability to develop instruments and run reports in REDCap

·        Excellent interpersonal skills

·         Experience at Duke with prospective and retrospective research

• Recognizes when typical agreements (MTAs, DUAs, DTAs, MOUs) are necessary and facilitates the process by coordinating with study teams and appropriate Duke offices.
• Applies knowledge of regulatory and Duke institutional policies and processes to create and maintain study documentation, DUA, and protocol submissions, and SOPs; serves as a departmental resource in this area.
• Participates in data governance and access provisioning and provides guidance to/participates in audits as needed.
• Participates or leads team meetings or multidisciplinary meetings with various stakeholders.
• Coordinate with external entities and community organizations to facilitate research partnerships, and process required contractual and regulatory submissions in support of these.
• Develop, maintain, follow, and train others on Standard Operating Procedures for regulatory processes.
• Represent the regulatory perspective and communicate requirements in meetings; may facilitate multidisciplinary meetings with various stakeholders.
• May maintain study-level documentation for a variety of studies, including those that are complex in nature.

• Develop and submit documentation for Data Use Agreements, Data Management Plans, and IRB protocols, including original submissions and amendments. Communicate with the IRB, ORC, OARC, OASIS, and ORA staff and document decisions appropriately. Serves as departmental subject matter expert on regulatory agreements.
• May develop or consult on consent plans and documents for participants in all types of studies.
• Prepares and submits documents as needed for regulatory and safety reporting to sponsors, data providers, and investigators.
• Recognizes, employs, clarifies, and conveys professional guidelines and code of ethics related to the conduct of clinical research to themselves and study teams.

• Enters and collects data for governance and regulatory purposes, and develops data collection tools and SOPs. May provide oversight or training to team members collecting or entering data.
• Ensures accuracy and completeness of data, recognizes data quality trends, and suggests re-mediation when appropriate. May develop tools for, and train others in, data quality assurance procedures.
• Recognizes, reports, and suggests/implements remediation for physical and electronic data vulnerabilities.
• Draft, develop, review, and maintain data flow, lifecycle, and management plans at the study, service center, and departmental levels. Creates guidance and advises others regarding data plans.
• Follows or develops SOPs to assist in documenting and maintaining documentation to facilitate data sharing.
• Creates clear visualizations to help communicate key information to stakeholders; documents and develops reports on project progress for teams and departmental leadership.

• Uses clinical research management systems (i.e., OnCore) to report protocol activities, manage the minimum footprints, SIP console, and other documentation as appropriate. May train others or provide quality assurance reviews for others.
• May prepare for, coordinate, and participate in site visits. Communicates effectively with sponsors and/or CROs.
• Ensures studies are conducted in compliance with institutional requirements and other policies.
• Prepares studies and data for closeout and archiving.

• May train or oversee others in the tasks above.
• Navigates processes and people involved in Duke clinical research, demonstrate organizational awareness and has the interpersonal skills necessary to get work done efficiently regardless of reporting relationship.
• Seeks opportunities to add relevant skills, learn new technologies, or attend external offerings applicable to the position and disseminate learnings to others. May serve on internal or external committees and workgroups.
• Uses advanced subject matter expertise in regulatory requirements of clinical research to propose and implement efficiencies and solve problems.

The Department of Population Health Sciences aspires to create a community built on collaboration, innovation, creativity, equity, and inclusivity of others without biases or prejudice of any kind. Our collective success depends on a robust exchange of ideas - an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, we are committed to diversity in the staff and faculty we hire, the policies we create, and the decisions we make.

Completion of an Associate's degree

Work requires a minimum of two years of research and/or regulatory experience. experience.A Bachelor's degree may substitute for 2 years of required

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.