RESEARCH PROGRAM LEADER, SR

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations: Works with institutional leaders and offices to handle complex issues related to contracts and agreements. Helps the research program resolve complicated contractual problems. Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). May train or oversee others. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Serves as an expert resource across all study teams within the research portfolio for navigating regulatory compliance with international studies. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program. Serves as an expert resource to address and correct findings. 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. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s). 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 research portfolio. May provide input for institutional SOPs. Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance. Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program. 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 effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies. Ethics: Serves as an expert in AE identification and documentation, including liaising with and being knowledgeable about other resources at Duke. 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: Under direct supervision from Biostatistician and PI may perform analyses on a variety of data formats and create data analysis plans. Prepares a wide variety of data formats for analysis. Provide support for various tools used for analysis and data management. Serves as an institutional resource on ECRFs, EDCSs, technologies, and software to ensure the highest quality data collection and capture. Actively encourages connections with stakeholders (e.g., statisticians) and institutional resources (e.g., ISO, IRB). Maintains study-level documentation for all studies, including those that are complex in nature (e.g., involving datasets from multiple sources, big data, or non-standardized data). Provides oversight and training and lends expertise to multiple study teams. Coordinates with institutional leadership on initiatives and priority setting to ensure appropriate QA processes. Oversees implementation of data quality processes across research portfolio. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Serves as an expert in data sharing, including liaising with and being knowledgeable about other resources at

Duke, and regulations and best practices. Serves as an expert in data standards, advising on appropriate standards for the types of research programs and projects they work on. Predicts areas of vulnerability in data flow across the research portfolio. Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis. Oversees implementation of data flow plans across the research portfolio. Ensures that study teams are familiar with and using data flow plan resources at Duke. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement, as relevant. Oversees implementation of new technologies and ensures continuous evaluation of technology solutions throughout the research portfolio. Develops reports on research program progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders. Science: Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. Serves as an expert resource to faculty, trainees, and staff for the development of protocols for complex investigator-initiated studies. Uses expertise in research design to provide significant contribution to protocols or research proposals. 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. Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information. Makes feasibility recommendations for multiple study teams/research program. Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies. Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Oversees implementation of operational plans across multiple research programs. Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines. Leadership: Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development. Keeps current with advances in the scientific area and considers the impact on the research program. Keeps self and team current with research updates by attending external offerings; applies learned material on the job. Plays key/leadership 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. Demonstrates resilience, leadership, and actively facilitates change for research portfolio. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research portfolio. 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. Description of Portfolio Responsibilities: (Effort 75%): Develops strategies to improve or maintain the effectiveness of the research program/shared resource. Engages large groups of diverse stakeholders and facilitates the development of actionable plans and measurable outcome goals. Manages progress of collaborating stakeholders toward achieving project/program goals. Establishes risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and direct staff in execution of plans. Provides overall leadership of large research program/shared resource provides guidance/mentorship as an operational subject matter expert to others who develop or manage large research programs or studies. Develops, negotiates, and oversees budgets. Allocates and forecasts resources. Oversees, supervises, or mentors staff who manage the day-to-day operations. Provides guidance to faculty investigators, divisional or Duke office leaders on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.). Provides significant intellectual contribution to the research program/shared resource, including substantial leadership in developing the scientific

content of research proposals and manuscripts. Establishes and maintains internal (Duke) and external communications to ensure successful research partnerships. Suggests hypotheses, research strategies, research partnerships, and research opportunities. Frequently represents research program or shared resource on behalf of the PI. This position will oversee the research studies within the Cardiac and ICU divisions within Anesthesiology. These are mostly inpatient protocols although often involve outpatient follow up visits. The nature of the studies requires significant collaborations due to the interdisciplinary components. This position will leverage established CRU relationships to develop an Anesthesiology multi-site network (aka an academic research organization, ARO) to enhance the efficiency with which multi-site protocols can be developed and conducted. This position will identify potential sites, complete site evaluations, and identify key stakeholders at the various sites. This position may seek funding to assist with the development of this network and would present internally and externally the pathways which were key to its development and the hindrances overcome. As the network is established, this position will ensure protocol feasibility within the network and negotiate budgets accordingly. This position will oversee clinical research studies within key complimentary divisions in the anesthesiology department. Although protocols will be mainly inpatient, follow up outpatient visits that leverage relationships with outpatient clinics and direct participant follow up is often required. Currently, we envision 8 single site protocols and 3-4 multi site protocols, the latter of which will provide the foundation for ARO development. 10-15 staff at Duke ranging from CRS Sr, CRC and CRC Sr. In addition, this position will maintain key stakeholder information from the various sites in the network. Estimated initial annual budget of $2.5M will be managed by the individual holding this position. To propel our research program to new heights and solidify its standing at the university level, we envision a comprehensive strategy utilizing the development of a multi-site network that champions equity, diversity, and inclusion (EDI) in every facet of our endeavors. This includes fostering an inclusive culture that values and celebrates differences. Our commitment encompasses both the patient population we aim to serve and the research staff who are part of the program. At the core of our vision is the acknowledgment that diverse perspectives drive innovation which can, in turn, further the advancement of how clinical research is conducted. Collaboration with investigators is pivotal to the success of the initiative. We will establish partnerships with researchers who share our commitment. This collaborative approach will facilitate knowledge exchange, broaden the scope of our research, and enhance the impact of our findings. Our vision extends beyond the confines of our research program; we will actively seek out and contribute to university-wide initiatives, sharing our learnings and best practices. By serving as a model, we hope to inspire other departments and programs. Type of Research: Manage the portfolio of personnel and projects within the Anesthesiology CRU. Special skills: Problem solving. Communication.

Minimum Qualifications
Education

Completion of a Bachelor's degree

Experience

Work requires a minimum of eight 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.