Research Program Leader, SR - NC State Remote or Hybrid
General Description:
This position will lead the development, implementation, and oversight of the PopHealth DataShare Research Core, including efforts to grow its portfolio of supported projects and resulting funding. Frequently lead communications with multiple research groups in the Duke University School of Medicine, partnering institutions, and sponsors, serving as primary liaison and public relations lead for the DataShare Core. Develop and coordinate wider program activities with responsibility for results in terms of costs and reporting requirements. The role will directly manage the operational team including clinical research and regulatory staff and will supervise two managers and teams in programming and biostatistics. They will also serve as expert resource when discussing the PopHealth DataShare with graduate/undergraduate students, clinicians, and senior staff leadership across the SOM and Duke University.
Specific duties and related competencies include:
Research program/portfolio management and development (45%):
Formulate and implement the short and long-range goals for the operation of clinical research and quality improvement initiatives under the PopHealth DataShare Research Core. Determine key indicators of DataShare success including number of awarded projects, publication rates/impact factors, and research program portfolio diversity; and establish processes for obtaining metrics through collaboration with the Department of Population Health Sciences research administration team, chief administrative director, study team members and other key DataShare stakeholders and collaborators. Monitor, report on, and evaluate DataShare effectiveness using reports generated from research administrative systems and through regular reviews of publications, research proposals, and protocols; investigate quarterly and annual trends, and recommend and implement modifications to improve DataShare effectiveness in the acquisition of study funding, establishing and maintaining multidisciplinary collaborations, the acquisition of strategic data assets; and in the dissemination of high-impact research.
Related Competencies:
- Develop strategies to improve or maintain the effectiveness of the research program/shared resource.
- Engage large groups of diverse stakeholders and facilitates the development of actionable plans and measurable outcome goals.
- Manage progress of collaborating stakeholders toward achieving project/program goals.
- Establish risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and direct staff in execution of plans.
- Provide overall leadership of large research program/shared resource provides guidance/mentorship as an operational subject matter expert to others who develop or manage large research programs or studies.
- Develop, negotiate, and oversee budgets, and allocate and forecast resources.
- Oversee, supervise, or mentor staff who manage the day-to-day operations.
- Provide guidance to faculty investigators, divisional or Duke office leaders on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.).
- Provide significant intellectual contribution to the research program/shared resource, including substantial leadership in developing the scientific content of research proposals and manuscripts.
- Establish and maintain internal (Duke) and external communications to ensure successful research partnerships.
- Suggest hypotheses, research strategies, research partnerships, and research opportunities.
- Frequently represent research program or shared resource on behalf of the PI.
Operations (30%):
Oversee, develop, and manage the day-to-day operations within the DataShare Research Core ensuring timely communications and adherence to regulations and guidelines. Work with department leadership to set annual core rates and fiscal year budgets; proactively review monthly financial and operational reports for variances; make adjustments as needed to ensure DataShare is operating at financial breakeven; oversee time tracking, billing and invoicing, and collection of funds. Adjust the revenue model as needed based on changes in infrastructure, demand for services, and other factors. Develop overall DataShare program milestones and timelines. Revise and implement DataShare operation strategies for proposal development and research protocol development as appropriate. Collaborate with DataShare Principal Biostatistician and DataShare Principal Analyst Programmer, who lead the biostatistics and programming teams, respectively, to formulate and develop strategies for acquisition of data assets and compliance and governance related to the use and security of secondary data sets.
Related Competencies:
- Work with institutional leaders and offices to handle complex issues related to contracts and agreements.
- Help the research program resolve complicated contractual problems.
- Serve as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes.
- Prepare for and provide support for study monitoring and audit visits, including support for the reviewer.
- Provide 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.
- Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio.
- May provide input for institutional SOPs.
- Provides expertise to research program team members in study level documentation. Provides oversight and training and lends expertise to research program.
- Prepares for and leads research program meetings.
- Ensures good communication within the research program, including mentoring staff to improve communication strategies.
Leadership (10%):
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 working in the department and in conjunction with PopHealth DataShare. Encourage leadership opportunities for PopHealth DataShare operations staff. Lead a committee or task force. Actively seek out continuing education and professional development opportunities for self, study team members and direct reports. Independently lead scientific or programmatic presentations and publications. Train staff and multiple study teams in various work responsibilities. Employ escalation and performance plans to correct behavior and performance problems 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 study, department, and institution in the conduct of clinical research lead by PopHealth DataShare. Maintain study specific and institutional training requirements for study teams and direct reports. Develop solutions to proactively ensure DataShare, department, or division compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research through the strategic acquisition of data assets utilizing data collected from underserved populations.
Related Competencies:
- 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.
Ethical and participant safety considerations (5%).
Serve as expert resource to teams as they design studies to ensure ethical conduct. Independently develop work instructions and standard operating procedures related to safety and security of Data Share data assets. Serve as an expert resource for development and implementation of RDSPs, DSMPs, and conflict of interest plans across multiple studies or study teams within the DataShare.
Data (5%):
Make determinations and collaborate with institutional and external stakeholders regarding complex data use agreements, material transfer agreements, and contracts for the acquisition of clinical registry data, electronic medical records, biospecimens, device data, and administrative healthcare claims data. At the institutional level, assists with development of, or develops data provenance and security training sessions, guidelines, and policies.
Related Competencies:
- Predicts areas of vulnerability in data flow across the research portfolio.
- Serves as an expert resource across research portfolio with regard to data capture, storage, management, quality, and preparation for analysis.
- Oversees implementation of data flow plans across the research portfolio.
- Ensures that study teams are familiar with and using data flow plan 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.
Communication and team science (5%).
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 clinical research staff liaising with sponsors, subcontractors, or vendors. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Special skills include:
- Strong and effective written and verbal communication.
- Detail-oriented.
- Funding and budget development.
- IT/data security knowledge for storage of highly sensitive data/PHI.
Minimum Qualifications
Education
Completion of a Bachelor's degree
Experience
Work requires a minimum of eight years of research experience (e.g., experience. research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related
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