Duke University:

Duke University was created in 1924 through an indenture of trust by James Buchanan Duke. Today, Duke is regarded as one of America’s leading research universities. Located in Durham, North Carolina, Duke is positioned in the heart of the Research Triangle, which is ranked annually as one of the best places in the country to work and live. Duke has more than 15,000 students who study and conduct research in its 10 undergraduate, graduate and professional schools. With about 40,000 employees, Duke is the third largest private employer in North Carolina, and it now has international programs in more than 150 countries.

Research Project Manager – SSRI

Job Code 1007, Job Level 68

OVERVIEW

Provide regulatory oversight and direction for investigators within the Institute or Center. In partnership with center/institute leadership, assist research teams in solving regulatory issues of moderate to complex scope, with an emphasis on those involving protected data and complex contractual and protocol arrangements. Coordinate with institute leadership and the Office of Research to ensure research teams’ compliance with approved protocols, approved contractual arrangements and institutional/other policies. Collaborate with research support offices and technical partners at Duke and beyond, to determine and implement appropriate processes for managing compliant use of protected data for research.

Work Performed

Regulatory oversight and direction (50% effort)

• Serve as an expert resource to multiple study teams within the institute regarding regulatory and institutional policies and processes. Recognize when agreements between Duke and outside entities are necessary and help teams navigate between appropriate parties within the Duke environment and with external data providers and funders. Develop, oversee adherence, and train research teams within the institute in the use and development of workflows, tracking tools, and standard operating procedures (SOPs).
• Provides regulatory oversight, training, and expertise for multiple study teams within the center or institute. Provide training and oversight to staff and faculty who develop and submit documentation to Institutional Review Board (IRB), information security offices, research contracting groups, funders, data providers, and other internal/external parties. Develop and submit documentation on behalf of research teams as needed. Assist SSRI and individual research teams with regulatory reporting to sponsors and other agencies.
• Work with institutional offices to ensure that research teams’ activities are in compliance with data provider requirements, executed agreements, and other regulatory documentation. For data held within virtual protected environments, provide detailed review of this documentation in advance of research team’s execution of various activities.
• In collaboration with Duke’s resource support offices, serve as an expert resource to multiple study teams within the institute regarding agreements with external and internal data providers.
• Recommend and lead individual research team implementation of improved processes, policies, and systems to ensure regulatory compliance and data security. May develop or review research data security plans (RDSPs) for multiple study protocols. Map, or help teams map, a protocol’s data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis.

Portfolio Management (25%)

• Assist SSRI leadership in predicting areas of vulnerability in regulatory requirements, data flow, data quality processes and data security. Help SSRI and individual study teams work through solutions.
• Serve as liaison between central offices and SSRI. Provide reports to center and institute leadership, as well as the Office of Research, as needed.

Research process optimization and training (25%)

• Recognize and escalate organizational or study level issues that could be optimized to improve research process. Actively facilitate and lead research teams’ adoption of change as policies and processes evolve. Uses advanced subject matter expertise in the areas of data/regulation to solve problems across multiple study teams.
• Train others to communicate effectively within teams and facilitate resolution of issues associated with teams or communication.

[RF1] Preferences:

• A minimum of five years of experience in research administration, research operations or regulatory environment. Experience in a legal, human research protections, academic research, or IT security program preferred.

• Technical or legal writing proficiency, especially writing and executing Data Use Agreements and IRB protocol documents in an academic setting.

• Excellent organizational skills; familiarity and knowledge of academic research processes.

• A thorough understanding of standard DUA contractual elements and the ability to discuss legal terms with external organizations and Duke faculty and student researchers.

• Detail-oriented with high degree of computer literacy and competency in the use of office applications.

• Knowledge of data security, privacy, and human subject protections issues and applicable laws and policies.

• Excellent interpersonal skills and demonstrated abilities in collaboration and consensus building.

• Initiative, resourcefulness and the ability to self-direct, problem-solve, and follow processes to completion. A

collaborative problem solver who can take initiative and set priorities while being flexible.

• Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).

• Ability to utilize interpersonal and communication skills to get work done effectively.

• Knowledgeable in the regulatory landscape, especially as it relates to sensitive data.

• Knowledge of Duke institutional policies and processes is strongly desired. Experience with external and government data providers is beneficial.

[RF1]ur job description includes:

Experience: Work requires five years of experience in research administration, law, or related work. Legal experience preferred. A related professional or graduate degree may offset required years of experience on a 1:1 basis, e.g. a two-year master's degree in lieu of two years of experience, or an equivalent combination of relevant education and/or experience.

Preferences:

• A minimum of two years of experience in an administrative or regulatory environment. Experience in a legal, human research protections, academic research, or IT security program preferred.

• Technical or legal writing proficiency, especially writing and executing Data Use Agreements and IRB protocol documents in an academic setting.

• Excellent organizational skills; familiarity and knowledge of academic research processes.

• A thorough understanding of standard DUA contractual elements and the ability to discuss legal terms with external organizations and Duke faculty and student researchers.

• Detail-oriented with high degree of computer literacy and competency in the use of office applications.

• Knowledge of data security, privacy, and human subject protections issues and applicable laws and policies.

• Excellent interpersonal skills and demonstrated abilities in collaboration and consensus building.

• Initiative, resourcefulness and the ability to self-direct, problem-solve, and follow processes to completion. A collaborative problem solver who can take initiative and set priorities while being flexible.

Minimum Qualifications

Education

Master's degree in social sciences or similar curricula preferred.

Experience

Minimum of three years of related program evaluation experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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 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.