RESEARCH PROGRAM LEADER
RESEARCH PROGRAM LEADER
General Internal Medicine
Set up unit-wide systems, policies, including oversight, training, and management related to subject screening
subject level documentation
Investigational Product (IP) Management
Monitoring and Audits
May conduct study visits independently. Serve as a unit/departmental resource and train others regarding preparation and conduct of study visits, creation of SOPs, and implementation of operational plans. Create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Implement innovative solutions to maximize recruitment and retention Provide oversight and serve as expert resource to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource when addressing and correcting findings. Oversee the collection of adverse event information for an entire unit or department Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Possess thorough understanding of intellectual property rights, inventions, patents, and technologies. Coordinate with Duke core services such as Investigational Drug Service, Biobank, etc. Coordinate necessary agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.). Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.
Serve as expert resource to division study teams to assure ethical conduct of research across all study populations. Articulate the difference between clinical care and clinical management of research participants. Train staff in ethical conduct of research. Serve as a resource for development and implementation of RDSPs and DSMPs and COIs across multiple studies or study teams.
Predict areas of vulnerability for data flow for multiple studies or across a unit, department or division. Design data flow plans that include elements related to data capture, storage, management, quality, and preparation for analysis; implement across multiple studies or at unit, department or division level. Independently design ECRFs and EDCs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each. Implement at the unit, division, or departmental level. Recommend and lead implementation of processes, policies, and systems to ensure data security and data provenance. Develop system/framework for QA processes for multiple studies or for entire unit. Develop quality assurance systems for research data; ensure that QA SOPs are updated and followed by study teams. Implement quality assurance systems across multiple studies, or across entire unit, department or division. reports. Recognize trends; escalate as appropriate. Make determinations regarding complex data contracts/agreements
Conduct and synthesize literature reviews independently Collaborate with various stakeholders.) to ensure adequate design, implementation and testing of study aims Develop proposals or protocols independently. Assess and determine solutions for operational shortcomings of proposals and protocols. Summarize and interpret study results, and determine application to future study procedures.
As a division leader, facilitate committees, task force, or ad hoc groups as necessary. Lead scientific or programmatic presentations and publications. Serve as a unit-wide expert resource for issues related to professional guidelines and code of ethics. Maintain training requirements and develop solutions to proactively ensure division's compliance with training requirements. Create strategies that enhance cultural diversity and cultural competency in the design and conduct of clinical research.
Study and Site Management:
Make recommendations regarding appropriate feasibility, recruitment, and retention strategies. Provide expert guidance to study team members to ensure appropriate allocation of participant care expenses and troubleshoot, escalate, and resolve issues. Collaborate with the financial analyst to establish financial monitoring systems. Determine when financial reports are not working as planned and collaborate with sponsor and financial managers to troubleshoot. Develop study budgets. Use system reports to ensure division compliance with institutional requirement/policies; assist team members with understanding these requirements and policies. Oversee study teams' maintenance of Delegation of Authority Logs and training of key personnel. Work with sponsors and study. Provide feedback to the study team members; and serve as an institutional resource to the study visitors. Develop systems and documents including process flows, training manuals, and standard operating procedures to be used division-wide. Develop and implement closeout procedures.studies.
Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Responsible for items listed above, and in addition, recognize when team member communication is not going well and troubleshoot the issue.
Description of Portfolio and Clinical Responsibilities:
Manage and monitor the program portfolio, or shared resource by employing strategies to reach established short- and long-term goals. Monitor success using relevant reports. Investigate trends and implement modifications to improve the research program Determine scope of and changes to research program/portfolio operations; develop, negotiate, and oversee budgets; allocate and forecast resources. Oversee staff who manage day-to-day operational issues.Ensure that institutional communications are shared with the staff within the research program. Establish and maintain internal Duke and external communications to accomplish program objectives and ensure successful research partnerships. Represent the research program at the institutional level and collaborators external to Duke.
RPL will be responsible for diverse research portfolio management of investigators and faculty to include personnel management/projection, budget development and justification, financial feasibility and accountability, training new staff, liaise with sponsors/vendors, subcontractors
This position is new and will manage the research portfolio of delegated investigators within General Internal Medicine
This position will manage CRC staff and others as portfolio expands, with funding sources determined by research studies.
This position will collaborate with external sources to facilitate research operational logistics as studies dictate. This position may represent Duke at conferences/meetings outside the institution.
Type of Research
This position will provide operational and logistical oversight of research portfolios led by investigators and faculty in the Duke Department of General Internal Medicine (GIM). This position will manage Clinical Research Coordinators and other research personnel as appropriate.This position will report to the Department of Medicine Assistant Research Practice Manager for GIM.
1280 RESEARCH PROGRAM LEADER
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, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.
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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.
1.Completion of a bachelor's degree plus a minimum of four years of research experience.
2.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). Must be highly proficient in organizational, management, and communication skills.
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.