Senior Research Program Leader in Office of Clinical Research

North Carolina, United Sates
03 Dec 2018
End of advertisement period
03 Feb 2019
Contract Type
Full Time

Job Description

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. 

Occupational Summary

Lead the development, implementation, and oversight of research programs led by investigator(s) and faculty in the Duke University School of Medicine; oversee a variety of complex duties involved in the analysis, interpretation, and communication of research program or portfolio data; lead content and direction of research program or portfolio; lead and report on efforts to obtain and manage study or program funding. Frequently lead communications with other research groups or programs, serving as primary liaison and public relations lead to research program. Develop and coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.

Work Performed

Essential Duties (Program portfolio)

1. Research program/portfolio management and development. Formulate and implement the short and long-range goals for the operation of the research program.

  • Determine key indicators of program success, and set up processes for obtaining metrics. Monitor, report on, and evaluate program effectiveness using qualitative and quantitative research techniques; investigate trends, and recommend and implement modifications to improve program effectiveness.

2. Research program operations. Oversee, develop, and manage the day-to- day operations within a research program or network, ensuring timely communications and adherence to regulations and guidelines. ate.

3. Research Program/portfolio communications and dissemination. Coordinate and create large program initiatives, public events and other related programs. 

4. Research Program financial management. Lead investigations and communications related to program funding opportunities. Lead development and negotiation of budgets and justifications for research program/proposals, employing strategies for long-term management of funds. 

  • Coordinate with others to monitor financial program milestones and report appropriately. Create and communicate information related to the financial stability of program to stakeholders. 
  • Communicate with sponsors, subcontractors, and/or vendors. Mentor or train junior staff in research program financial management tasks.

5. 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.  

  • 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. 

  • Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Oversee the creation and use of queries, summaries, and reports. Map protocol data flow and predict areas of vulnerability. 
  • 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.

  • 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. 
  • 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. Oversee study teams' compliance with training and maintenance of Delegation of Authority Logs.

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. 
  • Maintain 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 intended to be an exhaustive list of duties and responsibilities.

Requisition Number: 100005613 
Location: Durham 
Job Family Level: 69
Exempt/Non-Exempt: Exempt
Full Time / Part Time: FULL TIME
Regular / Temporary: Regular
Shift: First/Day

Minimum Qualifications

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.


Work requires one of the following:

  1. Completion of a bachelor's degree plus, a minimum of eight years of research experience.
  2. Completion of a master's degree, plus a minimum of six years of research experience.
  3. Completion of a doctoral degree, plus a minimum of four 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: ID106718BR