RESEARCH PROGRAM LEADER - SON


diversity employer



RESEARCH PROGRAM LEADER - SON
SON-FACULTY AND STAFF

Operations: Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Create unit-wide (and collaborate to create institution-wide) policies and guidances regarding conduct of study visits. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc. Oversee maintenance of subject level documentation. Implement innovative solutions to maximize recruitment and retention Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings. Oversee the collection of adverse event information 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. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks.

Ethics: Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety. Develop documents related to safety and security (e.g., RDSPs, COIs, DSMPs). Coordinate efforts of external monitoring boards. Data: Map protocol data flow and predict areas of vulnerability. Determine solutions for vulnerabilities for data flow plans for multiple studies. Independently design ECRFs and EDCs to collect data according to protocol. Select methods of data capture and discuss advantages and disadvantages of each. Recognize and report vulnerabilities related to security of physical and electronic data. Suggest and implement solutions to vulnerabilities related to security of data and data provenance Oversee the creation and use of queries, summaries, and reports. Recognize trends; escalate as appropriate. 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

Science: Conduct and synthesize literature reviews independently Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. Assist with development of research proposals or protocols. Summarize study results Leadership: Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. 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 training requirementsand develop solutions to proactively ensure study team members' compliance with training requirements. Study andSite Management: Make recommendations to investigators and oversight organization regarding appropriate feasibility, recruitment, and retention strategies. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee 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. Takepart in or lead closeout and document storage activities

Communication: Serve asprimary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. 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:

Portfolio Management (Effort 95%): 1. Research program/portfolio management and development. Assist in formulating and implementing the short and long range goals for the operation of the Research Areas of Excellence (RAE). Assist with monitoring research program effectiveness; help investigate trends, and implement modifications to improve program effectiveness. 2. Research program operations. Coordinate with the Program Coordinator and RAE Leads to facilitate and manage the day to day research program operations. Revise and implement portfoliostrategies as appropriate. 3. Research Program/portfolio communications and dissemination. Work with the Program Coordinator to facilitate public events, workshops and other related programs within the RAEs. Assist with or develop publications and presentations; represent program at conferences and meetings as delegated by the RAE Leads. 4. Research Program financial management. Assist the pre- and post-award grant management specialists and Research Area Leads with portfolio funding opportunities. Assist with or lead the development and negotiation of budgets and justifications for research program/proposals; utilize strategies for long-term management of funds. Serve as a resource to help monitor, verify, and reconcile expenditure of budgeted RAE funds as appropriate. Coordinate with others to monitor and report on financial portfolio milestones. Serve as a liaison with sponsors, subcontractors, and/or vendors as needed.

Clinical responsibilities: • Other: Type of Research Manage activities of the research areas of excellence (RAE) at Duke University School of Nursing (DUSON) led by the 4 RAE leads and conducted by faculty. Perform and/or oversee a variety of complex duties involved in the development and analysis of research programs or portfolios; assist with content and direction of research program or portfolio; contribute efforts to obtain and manage study or program funding in these areas.

Special Skills • Can easily use computing software and web based applications (e.g., Microsoft Office products, grants.gov, and the electronic medical record). • Strong knowledge of research and analytic methods, statistics and presentation techniques. • Ability to work well in interdisciplinary groups. • Excellent written and oral communication skills. • Time management. • Planning and organization. • Leadership and management. • Creativity.

Requisition Number
401297499

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1280 RESEARCH PROGRAM LEADER

Job Family Level
68

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
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.

Education

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

Auto req ID

92008BR

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.

PI98727226