RESEARCH PROGRAM LEADER


diversity employer



RESEARCH PROGRAM LEADER
Head and Neck Surgery Communications Sci

Occupational Summary

Manage the activities of research programs led by investigator(s) and faculty in the Duke University School of Medicine; perform and/or oversee a variety of complex duties involved in the collection, compilation, documentation and analysis of research program or portfolio data; assist with content and direction of research program or portfolio; assist with efforts to obtain and manage study or program funding. Frequently interact with other research groups or programs, serving as primary liaison and public relations lead to research program. Coordinate wider program activities with responsibility for results in terms of costs, methods, and reporting requirements.

Work Performed

Essential Duties (Program portfolio - >25%) 1.Research program/portfolio management and development. Assist in formulating and implementing the short and long-range goals for the operation of the research program. Assist with monitoring and evaluating program effectiveness using qualitative and quantitative research techniques; help investigate trends, and implement modifications to improve program effectiveness. 2.Research program operations. Coordinate 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. Revise and implement program operation strategies as appropriate. 3.Research Program/portfolio communications and dissemination. Coordinate public events and other related programs. Coordinate public relations activities including writing promotional materials and external communications. Assist with or develop publications and presentations; represent program at conferences and meetings. Serve as the primary point of contact for program (s). May mentor or train junior staff in research program/portfolio communications. 4.Research Program financial management. Assist with or lead investigations and communications related to program 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. Recognize allowable expenses based on financial guidelines. Serve as a resource to help monitor, verify, and reconcile expenditure of budgeted program funds as appropriate. 5.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.

Essential Duties (Research studies - <75%) 1.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. Serve as a resource and train others regarding preparation and conduct of study visits, creation of SOPs, and in implementing operational plans. Evaluate processes to identify issues related to recruitment and retention rates, and implement innovative solutions to maximize recruitment and retention. 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. Direct study teams# compliance with collection of AE information. Serve as a resource to junior staff, division, or department with regard to institution and sponsor-specific reporting requirements. 2.Ethical and 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. 3.Data management and informatics. Use and 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. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data. Oversee the creation and use of queries, summaries, and reports. Map protocol data flow and predict areas of vulnerability. Develop and implement system/framework for QA processes and data security for multiple studies or for entire unit. 4.Scientific concepts and research design. Conduct and synthesize literature reviews, and independently develop proposals or protocols. Assess and determine solutions for operational shortcomings of proposals and protocols. Identify and collaborate with various stakeholders to ensure adequate design, implementation, and testing of study aims. 5.Leadership and professionalism. Assist colleagues in identifying efficiencies and improving process. May provide significant contribution and influence upon research work, activities, or productivity of project teams or across multiple groups. Encourage leadership opportunities for staff within a small work group. Lead a committee or task force. Actively seekout continuing education opportunities for self and study team members. Independently lead scientific or programmatic presentations and publications. Maintain training requirements. Develop solutions to proactively ensure unit, department, or division compliance with training requirements. 6.Study and site management. Provide expert guidance to study team members to ensure participant care expenses are handled; troubleshoot, escalate, and resolve issues. 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. Use system reports to ensure unit, division, or department compliance with institutional requirements and other policies; assist team members with understanding these requirements and policies. Oversee study teams# compliance with training and maintenance of Delegation of Authority Logs. 7.Communication and team science. Lead team meetings. Include others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. Take action when communication has stalled with sites, CROs, or sponsors. Act as an expert resource to junior staff liaising with sponsors, subcontractors, or vendors. Knowledge, Skills and Abilities Can easily use computing software and web-based applications (e.g., Microsoft Office products and the electronic medical record).

Requisition Number
401253597

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

89262BR

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.

PI98302852