Research Program Leader,Office of Clinical Research
The research position for which you are applying is not specific to a clinical research area. Instead, your resume may be shared across the Duke School of Medicine in order to increase the visibility and likelihood of matching eligible candidates with open positions specific to the job title for which you have applied.
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.
Essential Duties (Program portfolio)
- Research program/portfolio management and development. Assist in formulating and implementing the short and long-range goals for the operation of the research program. Assist with monitoring and evaluating program effectiveness using qualitative and quantitative research techniques; help investigate trends, and implement modifications to improve program effectiveness.
- Research program operations. Coordinate and manage the day-to-day operations within a research program or network, ensuring timely communications and adherence to regulations and guidelines. Develop program milestones and timelines.
- Research Program/portfolio communications and dissemination. Coordinate public events and other related programs. Coordinate public relations activities including writing promotional materials and external communications.
- Research Program financial management. Assist with or lead investigations and communications related to program funding opportunities. Assist with or lead the development and negotiation of budgets and justifications for research program/proposals; utilize strategies for long-term management of funds.
- Institutional liaison. Liaise with other programs, offices and departments at Duke to coordinate program business and to accomplish program objectives; interface with external organizations to ensure cooperative efforts are enhanced and resources are utilized.
Essential Duties (Research studies)
1. Clinical research operations. Provide oversight and training to study team members who screen, schedule, consent, maintain subject/study level documentation, and collect adverse event information for participants in a variety of studies. Serve as a resource and train others regarding preparation and conduct of study visits, creation of SOPs, and in implementing operational plans.
- Create, optimize, and oversee systems related to research specimens and train others in these tasks. Provide direction for preparation of study monitoring/audit visits. Correct audit/monitor findings.
- Develop IRB documents and train other staff in these tasks. Design and oversee implementation of best methods for management of IP. Serve as an expert resource for study teams, DUHS procurement, billing, and compliance for the proper handling of IP.
- Direct study teams' compliance with collection of AE information. Serve as a resource to junior staff, division, or department with regard to institution and sponsor-specific reporting requirements.
- Possess thorough understanding of intellectual property rights, inventions, patents, and technologies.
2. Ethical and participant safety considerations. Provide division or department-wide training in ethical conduct of research. Serve as expert resource to teams as they design studies to ensure ethical conduct.
- Independently develop documents related to safety and security. Serve as an expert resource for development and implementation of RDSPs, DSMPs, and Conflict of Interest plans across multiple studies or study teams.
3. Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software. Independently design Case Report Forms to collect data according to protocol. Select methods of data capture and implement at the unit level.
- Make determinations regarding complex data contracts and agreements.
4. Scientific concepts and research design. Conduct and synthesize literature reviews, and independently develop proposals or protocols. Assess and determine solutions for operational shortcomings of proposals and protocols.
- Summarize and interpret study results, and determine application to future study procedures. Determine operational/statistical elements needed for conduct of clinical and translational studies.
5. Leadership and professionalism. Assist colleagues in identifying efficiencies and improving process. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups.
- Train staff and multiple study teams in various work responsibilities. Employ escalation and performance plans as needed.
- Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, and institution.
- Maintain training requirements. Develop solutions to proactively ensure unit, department, or division compliance with training requirements.
- Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.
6. Study and site management. Provide expert guidance to study team members to ensure participant care expenses are handled; troubleshoot, escalate, and resolve issues. Develop study budgets.
- Coordinate operational plans for multiple research studies. Develop systems and documents including process flow, training manuals, and standard operating procedures to be used unit, department, or division- wide.
- Work with sponsors/study teams to arrange required training. Lead site initiation, monitoring, and closeout visits and activities; provide feedback to the study team members.
- Inform investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies. Determine and implement alternative solutions to accomplishing recruitment and retention milestones.
- Use system reports to ensure unit, division, or department compliance with institutional requirements and other policies; assist team members with understanding these requirements and policies.
7. Communication and team science. Lead team meetings. Include others in decision-making, and escalate issues appropriately.
- Communicate with sponsors, subcontractors, or vendors. Take action when communication has stalled with sites, CROs, or sponsors. Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors.
- Maintain training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements.
- Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
This is not an exhaustive list of duties and responsibilities for this position.
Requisition Number: 100005612
Duke Entity: MEDICAL CENTER
Job Code: 1280 RESEARCH PROGRAM LEADER ;
Job Family Level: 68
Full Time / Part Time: FULL TIME
Regular / Temporary: Regular
Duke University 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 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.
Required Qualifications at this Level
- Completion of a bachelor's degree plus a minimum of four years of research experience
- Completion of a master's degree plus a minimum of two years of research experience.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
Auto req: ID106717BR