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.
Operations: For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices. 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. Participates in or leads the development of institutional policies and guidance documents about managing investigational product (IP). Serves as expert resource and trainer to implement and comply with systems for managing and documenting IP. 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. Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training in screening activities to multiple study teams. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. May provide input for institutional SOPs. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. May train or oversee others. 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 research program meetings. 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: Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. 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. 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 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, as relevant. Oversees implementation of new technologies and ensures continuous evaluation of technology solutions throughout the research portfolio.
Science: Assists with or contributes to the development of funding 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. 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 research program, including at multiple sites. 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 research updates and advances in the scientific area, considers the impact on the broad research portfolio, and oversees necessary implementation. Serves in a leadership capacity with internal and external groups (e.g., speaks at events, leads institutional initiatives or committees). Develops and implements solutions at the institutional level to improve the research process. Uses expertise and acumen to influence change at the division, department, or CRU level. 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 activities of other managers to accomplish goals of the broad research portfolio.
Description of Portfolio Responsibilities: (Effort 50%): 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. Manages the research program or shared resource operations. Monitors and adheres to the established budget, and assists with budget development. Ensures that institutional communications are shared with research program staff and faculty. Maintains communication within program and with other departments or offices to accomplish the program objectives. Manages, mentors, and/or trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
will support applied genomics and precision med and the biorepository. 12 studies that span community research, clinic at Durham regional, emergency medicine - screening for enrollment into a CAGPM study, biorepository, inpatient research studies 5 staff w budget range is approx $3 million for all coordinates proposals with external sites and visitng those sites for monitoring and to set up those projects. They will work with the internal finance and ARPM, preaward teams
Type of Research: infectious disease population. Complex device trials, community and some randomization, blinded projects. Genetics projects - multisite and acting as ARO for that trial
Special skills: management of staff and projecting effort across multi projects. WOrking and collaborating w CRU and project managers
Minimum Qualifications Education
Work requires an Associate's degree
Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required 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.
As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.