RESEARCH PROGRAM LEADER
RESEARCH PROGRAM LEADER
DCI CANCER CONTROL (CPDC)
This is a 100% sponsored funded position.
Manage the activities of research programs led by principal investigator (PIs) & faculty for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Cancer Control & Population Sciences - Epidemiology Program Team. Perform and/or oversee a variety of complex duties involved in the collection, compilation, documentation & analysis of research program or portfolio data; assist with content & direction of research program or portfolio; assist with efforts to obtain & manage study or program funding. Frequently interact with other research groups or programs, serving as primary liaison & public relations lead to research program.
Program Portfolio-Assist in formulating & implementing the short & long-range goals for the operation of the research program. Coordinate & manage the day-to-day operations within a research program or network, ensuring timely communications & adherence to regulations & guidelines. Develop program milestones & timelines. Revise & implement program operation strategies as appropriate. Assist with or lead investigations & communications related to program funding opportunities. Assist with or lead the development & negotiation of budgets & justifications for research program/proposals; utilize strategies for long-term management of funds. Recognize allowable expenses based on financial guidelines. Serve as a resource to help monitor, verify, & reconcile expenditure of budgeted program funds as appropriate. Coordinate with others to monitor & report on financial program milestones. Serve as a liaison with sponsors, subcontractors, and/or vendors. Assist with financial forecasting of staff. Liaise with other programs, offices & departments at Duke to coordinate program business & to accomplish program objectives; interface with external organizations to ensure cooperative efforts are enhanced & resources are utilized.
Operations- Screen participants for minimal risk studies. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in minimal risk studies. Assist with addressing and correcting findings from study monitoring and study audit visits. Have familiarity with intellectual property rights, inventions patents, and technologies. Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc. Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics- Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards.
Data - Independently design ECRFs and EDCs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each. Implement at the unit, division, or departmental level. Develop system/framework for QA processes for multiple studies or for entire unit. Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division reports. Recognize trends; escalate as appropriate. Oversee implementation of contracts and agreements within unit or department
Science - Conduct and synthesize literature reviews independently Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims. Summarize and interpret study results, and determine application to future study procedures.
Leadership - 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. Maintain Duke and project specific training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study & Site Management- Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with 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. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Lead site initiation activities Develop protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Coordinate operational plans for multiple research studies. Take part in or lead closeout and document storage activities
Communication- Take action when communication has stalled with sites, CROs, sponsors. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members. Take an active role in including others in decision-making.
And other work as assigned.
The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.
1280 RESEARCH PROGRAM LEADER
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System may include essential job 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.
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
The preferred candidate will have clinical research experience, training, and education
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
- Excellent written, oral and conversational communication skills to effectively work with diverse groups.
- Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills.
- Excellent time management skills needed to prioritize among many competing priorities.
- Attention to detail needed to operate accurately and effectively in the regulatory environment.
- Mastery of Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems including eIRB and Microsoft Access.
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.