RESEARCH PROGRAM LEADER

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

This position will manage two major programs in the Pulmonary division: 1. Duke Interstitial Lung Disease (ILD) Program which comprises of treatment clinical trials, as well as research on the effect of the environmental factors on this disease. 2. Duke Pulmonary Vascular Disease Program which has a diverse portfolio of industry sponsored clinical trials as well as PI initiated projects with industry and federal funding. It will provide oversight for the conduct of multiple research projects from initial proposal development and start-up, budget development and financial management, IRB and regulatory submissions and maintenance, database development, subject enrollment and data collection through closeout. In addition, this position will have active contribution to manuscript preparations and poster presentations; it will also facilitate research collaborations with various institutions and organizations.

Operations:

• For complex scenarios, recognizes when agreements are necessary within the research program. Facilitates the process by coordinating with study teams and appropriate Duke offices.
• Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).
• Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes.
• Provides direction to multiple study teams/research program to prepare for study monitoring and audit visits. Provides oversight, training, and expertise to multiple study teams/research program regarding participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require DUHS billing.
• Serves as an expert resource for multiple study teams/research program for participant retention. Liaises with other resources at Duke to optimize retention rates. Develops and oversees the implementation of strategies for meeting recruitment goals for the research program(s).
• Serves as an expert to research program team members in the area of screening. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio.
• Creates, optimizes, and oversees the systems for managing specimens for multiple study teams/research program. Serves as an expert resource and trainer in specimen collection, processing, preparation, shipping and maintenance.
• Provides expertise to research program team members in study level documentation. Serves as an expert resource and trainer to multiple study teams/research program for preparing and conducting complex study visits, developing tools, and implementing operational plans.
• Prepares for and leads effective facilitation of research program meetings in order to achieve objectives. Ensures good communication within the research program, including mentoring staff to improve communication strategies.
  
  Ethics:
  
  
• Ensures that multiple study teams/research program team members are appropriately identifying and documenting adverse event information.
• Provides oversight and training to multiple study teams/research program team members who conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. Provides oversight and training to multiple study teams/research program team members who develop the consent plan and document. Serves as an expert resource with regard to developing consent plans and documents for participants in a variety of studies.
• Provides oversight and training to multiple study teams/research program team members who develop and submit documentation and information for IRB review. Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
  
  Data:
  
  
• Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes.
• Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports. 
• Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Ensures that study teams are familiar with data flow resources at Duke.
• Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.
• Develops, oversees adherence, and trains to multiple study teams on the results reporting for patients and providers. Provides guidance based on CRU and institutional best practices.
• Develops reports on research program progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.
  
  Science:
  
  
• Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals.
• Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals.
• Independently develops protocols for multiple complex investigator-initiated studies within the research program. Uses expertise in research design to provide significant contribution to protocols or research proposals.
• Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation.
  
  Study and Site Management:
  
  
• Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs.
• Oversees use of systems and system reports to manage research participants' activities and tracking/marking financial milestones. Oversees use of systems and system reports to manage research protocol activities and maintaining current protocol information.
• Makes feasibility recommendations for multiple study teams/research program.  Develops and oversees processes to determine participation in trials. Oversees management of resources (staff, supplies, equipment) for multiple study teams/research program. May manage the budget for research studies.
• Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies.
• Oversees implementation of operational plans across research program, including at multiple sites.
• Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines.
  
  Leadership:
  
  
• Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development.
• Keeps current with advances in the scientific area and considers the impact on the research program.  Keeps self and team current with research updates by attending external offerings; applies learned material on the job. 
• Plays key/leadership role on committees and workgroups. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. 
• Develops and implements solutions that work within the existing leadership or organizational structure.
• Demonstrates resilience and actively facilitates the research program through change.
• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation within the research program.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals.
  
  
  Description of Portfolio Responsibilities: (Effort 50%):
  Determines short- and long-term goals of the research program/shared resource in collaboration with investigator(s).  Identifies research programs/shared resources gaps, constraints, needs, and milestones; helps develop operational sustainability plan and communicates with PI to plan necessary resourcing. Manages and documents all aspects of research project lifecycle including: initiation, planning, executing, monitoring, and closing.  Directs project staff in the execution of project activities in accordance with project plan and timeline. Communicates project/program progress with all major stakeholders and adjust plans and timelines according to feedback. Manages the research program or shared resource operations. Monitors and adheres to the established budget, and assists with budget development.  Ensures that institutional communications are shared with research program staff and faculty. Maintains communication within program and with other departments or offices to accomplish the program objectives. Manages, mentors, and/or trains staff. Maintains an awareness of regulations, policies, and resources relevant to research and therapeutic area and applies knowledge to the development and execution of operational plan. Ensures that all programs and projects are compliant with all relevant regulations and policies. Provides guidance to staff on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.). Provides intellectual contribution to the research program or shared resource, including developing and editing research proposals and manuscripts. Represents research program or shared resource on behalf of the PI at internal and external meetings.
  
  
  Type of Research:
  This position will manage complex research projects in the Pulmonary division funded by industry, federal and foundation grants.
  
  Special skills:
  Prior experience working with pulmonary patients. Proficient in a variety of pulmonary function /respiratory tests and procedures. Experience in coordinating with multiple teams or departments to achieve study goals    Experience with Epic, OnCore, iRIS , REDCap, PACE. Excellent communication, organization and interpersonal skills; ability to multitask and work independently in a multidisciplinary academic environment

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $ 76,811.00 to USD $130,576.00. Duke University considers factors such as ( but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

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

Completion of a Bachelor's degree

Experience

Work requires a minimum of four years of research experience (e.g.,research, clinical, interaction with study population, program coordination). A Master's degree may substitute for two years of related experience.

Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe 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.