Research Program Leader
Provide oversight and training to entire unit or department with regards to subject screening and recruitment. Set up unit-wide systems, policies related to subject screening. Provide oversight and training to entire unit or department with regards to maintaining subject level documentation. Set up unit-wide systems, policies related to subject level documentation. Serve as an expert resource with regard to conduct and documentation of consent.
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. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks.
Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc.
Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings.
Oversee the collection of adverse event information for an entire unit or department Provide input for AE reports. Serve as a resource to junior staff as well as the unit, department, or division staff with regard to institution and sponsor-specific prompt reporting requirements (timelines and forms).
Liaise with contact for final determination of safety event outcome. Serve as a unit, department, or division resource for development of IRB documents and for guidance on IRB communications.
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.
Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance. Develop system/framework for QA processes for multiple studies or for entire unit. Oversee implementation of contracts and agreements within department.
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.
Lead scientific or programmatic presentations and 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, division's compliance with training requirements.
Study and Site Management:
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. Develop study budgets. Use system reports to ensure unit, division, or department compliance with institutional requirement/policies; assist team members with understanding these requirements and policies. Develop systems and documents including process flows, training manuals, and standard operating procedures to be used unit, department, or division-wide. Develop and implement closeout procedures for multiple studies, unit, department, or division.
Take action when communication has stalled with sites, CROs, sponsors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.
Description of Portfolio and Clinical Responsibilities:
Manage the program, portfolio, or shared resource by employing strategies to reach established short- and long-term goals. Monitor the program or portfolio success using relevant reports. Investigate trends and implement modifications to improve the research program or shared resource effectiveness.Manage research program/portfolio and/or shared resource operations; monitor and adhere to established budget; manage and train staff.Ensure that institutional communications are shared with the staff within the research program. Establish and maintain internal Duke and external communications to accomplish program objectives and ensure successful research partnerships. Represent the research program and research areas at the institutional level and with collaborators external to Duke.
Work closely with the Chair, Vice Chair of Research and new research faculty members in the Department of Community and Family Medicine to manage the activities of research programs conducted by faculty.
Under the direction of the Vice Chair, develop, manage and support a wide variety of clinical/epidemiological and population health research projects. Assist in the support and mentorship of clinical and junior research faculty, as well as trainees at different levels, including: 3rd year medical students, graduate students and post-doctoral fellows. Oversee and supervise research staff and learners. 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.
Type of Research
Low risk - primary care patients/ healthy populations at risk of illness; epidemiological/ clinical/ population health research; all age groups; simple to complex study design; community and clinic based; studies based on existing large health surveys and EHR / registry data as well primary data collection from primary care, community clinics, and the community.
Requisition Number 401505398
Duke Entity MEDICAL CENTER
Job Code1280 RESEARCH PROGRAM LEADER
Job Family Level 68
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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1.Completion of a bachelor's degree plus a minimum of four years of research experience. 2.Completion of a master's degree plus a minimum of two years of research experience.
Knowledge and skills relating population health and community engaged research. Experience with data analysis, management and statistical analysis software. Excellent writing skills/ manuscript and grant writing/ literature review experience.