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

Manage the activities of research programs led by investigator(s) and faculty in the Duke University School of Medicine; perform and/or oversee a variety of complex duties involved in the collection, compilation, documentation and analysis of research program or portfolio data; assist with content and direction of research program or portfolio; assist with efforts to obtain and manage study or program funding. Frequently interact with other research groups or programs, serving as primary liaison and public relations lead to research program. Coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.

Work Performed

1. May conduct study visits independently. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Participate in or lead development of policies and guidance related to subject recruitment. Serve as an expert resource across unit or department. Conduct and document consent for participants in minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Participate in or lead development of policies and guidance related to monitoring and audits. Serve as an expert resource when addressing and correcting findings. Possess thorough understanding of intellectual property rights, inventions, patents, and technologies. Coordinate with Duke Core services such as Investigational Drug Service, Biobank, etc. Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications.

2. Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants Provide unit, division or department-wide training in ethical conduct of research. Serve as expert resource to study teams as they design studies, so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Serve as a resource for development and implementation of RDSPs and DSMPs and COIs across multiple studies or study teams. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria.

3. Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division. Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level. Serve as unit/departmental/institutional resource on ECRFs, EDCSs, technologies, and software to ensure highest quality data collection and capture May assist with development of, or develop, guidance and policies related to research data provenance and

security. Serve as unit/departmental resource to others regarding data provenance and security. Develop system/framework for QA processes for multiple studies or for entire unit. Develop unit/department - wide quality assurance systems for research data; oversee implementation. Oversee implementation of contracts and agreements within unit or department.

4. Conduct and synthesize literature reviews independently Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims Develop proposals or protocols independently. Assess and determine solutions for operational shortcomings of proposals and protocols. Summarize and interpret study results, and determine application to future study procedures.

5. Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Successfully lead a committee, task force, or ad hoc group at the division, unit, department, or institution level. Lead cross-functional committees or task forces charged with improving study processes. Independently lead scientific or programmatic presentations or publications. Serve as expert mentor to junior staff. Establish and assign the activities of multiple teams to accomplish study goals. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Maintain training requirements and develop solutions to proactively ensure unit, department, and division’s compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.

6. Determine and implement alternative solutions to accomplishing recruitment and retention milestones. Provide expert guidance to study team members to ensure participant care expenses have been set up correctly and that financial charges/expenses route in a timely manner; troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets. Provide leadership/training to entire unit/department with regard to compliance with institutional requirements and other policies Create unit-wide (and collaborate to create institution-wide) policies and guidance regarding operational planning Create unit-wide (and collaborate to create institution-wide) policies and guidance regarding study closeout and document storage.

7. Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Prepare for and lead unit, departmental, or division-wide meetings. Mentor junior staff to improve ability to participate in team efforts.

Required Qualifications at this Level

Education/Training:

1. Completion of a bachelor’s degree plus a minimum of four years of research experience OR

2. Completion of a master’s degree plus a minimum of two years of research experience

Experience:

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Skills

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

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.

Minimum Qualifications

Completion of a Bachelor's degree

Work requires a minimum of four years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related

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.