RESEARCH PROGRAM LEADER, SR


diversity employer



RESEARCH PROGRAM LEADER, SR
Population Health Sciences

Research program/portfolio management and development. Formulate and implement the short and long-range goals for the operation and determine key indicators of program success.

Monitor, report, and evaluate program effectiveness using qualitative and quantitative research techniques; investigate trends, and recommend and implement modifications to improve program effectiveness. Measurement Initiative research program operations.

Oversee, develop, and manage the day-to- day operations of the measurement research initiative, ensuring timely communications and adherence to regulations and guidelines.

Develop program milestones and timelines.

Measurement initiative research program/portfolio communications and 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.

Measurement initiative 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.

Provide recommendations of allowable expenses based on financial guidelines.

Serve as an expert resource to help monitor, verify, and reconcile expenditure of budgeted program 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.

Conduct financial forecasting of staff. Communicate with sponsors, subcontractors, and/or vendors.

Mentor or train junior staff in research program financial management tasks. Institutional liaison. 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.

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.

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. 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. 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. 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 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 seek out continuing education opportunities for self and study team members. Independently lead scientific or programmatic presentations and publications.

Train staff and multiple study teams in various work responsibilities.

Employ escalation and performance plans as needed.

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 and site management.

Provide expert guidance to study team members in the effective management of participant care expenses.

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.

Determine and implement alternative solutions to accomplishing recruitment and retention milestones.

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. 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.

Maintain training requirements.

Develop solutions that equate to study team members' compliance with training requirements.

Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research.

Make recommendations to investigative team.

Requisition Number
401288979

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1281 RESEARCH PROGRAM LEADER, SR

Job Family Level
69

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

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.

Auto req ID

91670BR

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.

PI98567027