RESEARCH PROGRAM LEADER
RESEARCH PROGRAM LEADER
DCI-Other Clinical Research
This is a 100% sponsored funded position.
This position will serve the research MDs and PhDs on the new Onco-Primary Team as a resource for grant, publication and protocol writing/submissions. This person will work with the investigators to develop goals for the team and will be involved in determining how to operationalize these goals. This person will represent the program at conferences/events and will work with sponsors to ensure the success of the program.
Description of Portfolio and Clinical Responsibilities
Operations - Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for minimal risk studies, or for other studies under direction. 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.
Collaborate to maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in minimal risk studies.
May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Assist with addressing and correcting findings from study monitoring and study audit visits.
Have familiarity with intellectual property rights, inventions patents, and technologies.
As appropriate, understand regulations related to investigational products with sponsors.
Coordinate with Duke core services such as Investigational Drug Service (IDS), Biobank, etc.
Recognize the need for agreements (e.g., Material Transfer Agreements, Investigational New Drug Applications, etc.).
Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.
Ethics - Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. Assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
Assist others with application of these principles. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial.
Data - 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. May assist with development of, or develop, guidances and policies related to research data provenance and security. Serve as unit/departmental resource to others regarding data provenance and security.
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. Oversee implementation of contracts and agreements within unit or department
Science - 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.
Leadership - Provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Successfully lead a committee, task force, or ad hoc group at the division, unit, department, or institution level.
Lead cross-functional committees or task forces charged with improving study processes. Independently lead 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. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.
Study and Site Management - Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately.
Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. Use system reports to ensure unit, division, or department 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 on study specific duties. Lead site initiation activities Develop 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.
Communication - Take action when communication has stalled with sites, CROs, sponsors. Prepare for and lead team meetings. Recognize when others need to be brought into the conversation and escalate appropriately. Expand on the ideas of peers or team members. Take an active role in including others in decision-making.
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.
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, 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.
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.
The preferred candidate will have clinical research experience, training, and education. Experience in grant, protocol and manuscript writing preferred.
Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).
Communication - Excellent written and oral communications skills, including telephone, email, and face-to-face communication.
Computer - Mastery of Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems.
Organization - Ability to organize and prioritize across multiple studies.
Critical Thinking and Problem Solving - Self-directed ability to analyze and assess a situation for problems and develop an acceptable solution.
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.