RESEARCH PROGRAM LEADER, SR
RESEARCH PROGRAM LEADER, SR
Heme Clinical Rsch
This is a 100% sponsored funded position. Thanks!
Lead the development, implementation, & oversight of research programs led by investigator(s) & faculty in the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the BMT Team. Oversee a variety of complex duties involved in the analysis, interpretation, & communication of research program or portfolio data; lead content & direction of research program or portfolio; lead & report on efforts to obtain & manage study or program funding. Frequently lead communications with other research groups or programs, serving as primary liaison & public relations lead to research program. Develop & coordinate wider program activities with responsibility for results in terms of costs, methods, & reporting requirements.
Description of Portfolio & Clinical Responsibilities
Research Program/Portfolio Management & 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, and evaluate program effectiveness using qualitative and quantitative research techniques; investigate trends, and recommend and implement modifications to improve program effectiveness.
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. Develop program milestones and timelines.
Research Program/Portfolio Communications & Dissemination-Coordinate and create large program initiatives, public events and other related programs. Develop and lead publications and presentations, and assist faculty and investigators in developing their presentations and publications; represent program at conferences and meetings. Serve as the primary point of contact for program(s).
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.
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. Establish collaborations within and outside the unit or department that enhance the successful research program environment. Build relationships with potential research collaborators throughout NC and the US to establish partnerships.
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. Coordinate necessary agreements.
Possess thorough understanding of intellectual property rights, inventions, patents, and technologies.
Ethical & 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.
Data Management & Informatics- Use & 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.
Scientific Concepts & 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.
Leadership & Professionalism- Assist colleagues in identifying efficiencies and improving process. Encourage leadership opportunities for staff within a small work group. Lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Independently lead scientific or programmatic presentations and publications.
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.
Study & 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. Develop and implement closeout procedures for multiple studies, or entire unit, department, or division.
Inform investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies.
Communication & Team Science- Communicate with sponsors, subcontractors, or vendors. Take action when communication has stalled with sites, CROs, or sponsors.
Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
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.
1281 RESEARCH PROGRAM LEADER, SR
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.
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.
PhD or Master's in a science field and ability to lead multi-center, international sites preferred.
- 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.