Duke Cancer Institute’s Healthcare Delivery Research Group (HCDR) within the Cancer Control and Population Sciences (CCPS) program works to develop and test practical solutions to facilitate learning health care delivery systems and evidence-based patient-centered care. The program brings together several existing programs at Duke and provides a platform for many new specialized cores by creating an innovation hub for investigators and academic entrepreneurs. The work of the HCDR team focuses efforts on the development and testing of research software platforms and clinical trials focused on patient-reported outcomes.
The research program leader is an integral part of the HCDR group. The research program leader functions as a project manager and focuses on the development, implementation and execution of projects related to improving quality health outcomes for cancer and palliative care patients. The work will have a particular focus on patient reported outcomes (PROs) with a strong emphasis on data management and system development. The research program leader is responsible to the Assistant Research Practice Manager for the HCDR group and works closely with clinical leaders, clinical staff, and internal and external project leaders. The program leader will also facilitate projects that yield actionable data for the betterment of decision making around treatments, improving clinical measures and focus on improving patient quality and satisfaction.
The program leader coordinates projects for minimal risk, non-therapeutic trials evaluating quality of life as related to cancer care and patient reported outcomes. Approximately 90% of the work expected in this position involves project management which includes data responsibilities, conducting literature reviews, providing leadership and general program management (which are outlined below). The additional 10% of the duties of this position will involve clinical operations duties such as recruiting, consenting, screening, enrolling, maintain subject level documentation, tracking patients throughout study duration. Also assists in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. Also assists with the coordination of efforts of external monitoring boards.
Approximate breakdown of project management responsibilities:
Leadership and program management:
- Serve as study/project lead on designated projects.
- Leads cross-functional committees or task forces charged with improving study processes.
- Independently leads scientific or programmatic presentations or publications.
- May serve as mentor to other staff.
- Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
- Maintain Duke and project specific training requirements.
- Makes recommendations to investigators and oversight organizations regarding appropriate feasibility, recruitment, and retention strategies.
- Ensures participant care expenses have appropriate financial routing in a timely manner.
- Monitors financial study milestones and report appropriately.
- Coordinates with finance and grants administration offices to participate in budget development as appropriate.
- Uses system reports to ensure compliance with institutional requirements and policies.
- Assists team members with understanding these requirements and policies.
- Oversees study teams' maintenance of Delegation of Authority Logs and training of key personnel on study specific duties.
- Leads site initiation activities
- Develops 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
- Designs data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis.
- Independently designs electronic case report forms (CRFs) and electronic data capture systems (EDCs) to collect data according to protocol.
- Selects methods of data capture and discuss advantages and disadvantages of each.
- May assist with development of guidelines and policies related to research data provenance and security.
- Develop system/framework for QA processes for multiple studies or for entire unit.
- Develop quality assurance systems for research
- Recognizes trends and escalates as appropriate
- Oversees implementation of contracts and agreements within department for designated projects.
- Literature reviews and independent research:
- Conduct and synthesize literature reviews independently.Collaborate with various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation and testing of study aims.
- Assist with development of research proposals or protocols.
- Summarize and interpret study results and determine application to future study procedures.
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.