Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Research Program Leader, Sr

100% Grant/Sponsor Funded 

 

Description of Portfolio Responsibilities:

Develops strategies to improve or maintain the effectiveness of the research program/shared resource. Engages large groups of diverse stakeholders and facilitates the development of actionable plans and measurable outcome goals. Manages progress of collaborating stakeholders toward achieving project/program goals. Establishes risk, cost, time, scope, communication and quality management plans, updates with input from stakeholders, and direct staff in execution of plans. Provides overall leadership of large research program/shared resource provides guidance/mentorship as an operational subject matter expert to others who develop or manage large research programs or studies. Develops, negotiates, and oversees budgets. Allocates and forecasts resources. Oversees, supervises, or mentors staff who manage the day-to-day operations. Provides guidance to faculty investigators, divisional or Duke office leaders on best practices in research study or program conduct (e.g., recruitment, consenting, study documentation, program evaluation, data capture, etc.). Provides significant intellectual contribution to the research program/shared resource, including substantial leadership in developing the scientific content of research proposals and manuscripts. Establishes and maintains internal (Duke) and external communications to ensure successful research partnerships. Suggests hypotheses, research strategies, research partnerships, and research opportunities. Frequently represents research program or shared resource on behalf of the PI. 

 

Mostly observational and some translational and clinical trials research. 10-12 projects in # Will oversee 2-3 RPLs Size of budgets vary in CAGPM division. $50,000- $5 million grants 

 

Position will serve as a liaison to the sponsor collaborators and other stakeholders to ensure successful completion of the research 

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). May train or oversee others. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Oversees the management and documentation of investigational products (IP) for multiple study teams/research program. Serves as an IP expert resource for study teams. Designs, implements, and optimizes methods for handling IP. Participates in or leads development of monitoring and audit training sessions and/or policies and guidelines for research program. Serves as an expert resource to address and correct findings. 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). Provides training. Develops, oversees adherence, and trains in the use and development of SOPs across research portfolio. May provide input for institutional SOPs. 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. Provides oversight and training and lends expertise to research program. 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 research program meetings. 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. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for IRB review. Communicates with the IRB staff and reviewers and handles issues appropriately. 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. May train or oversee others.

 

Data: Coordinates with institutional leadership on initiatives and priority setting to ensure appropriate QA processes. Oversees implementation of data quality processes across research portfolio. Follows required processes, policies, and systems to ensure data security and provenance. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. 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, as relevant. Oversees implementation of new technologies and ensures continuous evaluation of technology solutions throughout the research portfolio. 

 

Science: Independently develops funding proposals and grants, including leading the drafting of research aims, background, methods, etc. Independently reviews articles, synthesizes the literature, and uses to independently develop manuscripts or grant proposals. Serves as an expert resource to faculty, trainees, and staff for the development of protocols for complex investigator-initiated studies. 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. Mentors others in this area. 

Study and Site Management: Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. 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 the research resources and/or finance processes for a broad research portfolio. Works with central offices to optimize process. 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, leadership, and actively facilitates change for research portfolio. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve complex problems or foster innovation across the broad research portfolio. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Establishes and assigns activities of other managers to accomplish goals of the broad research portfolio.

 

Type of Research:Human subjects research w ID mostly obs. Inpt and community. Mostly investigator-initiated research. Some sponsored research. Coordinating w VA efforts 

 

Special skills: Experience w international collaborators. Fluent in Spanish is beneficial.

Minimum Qualifications

 

 

Education

Completion of a Bachelor's degree

 

Experience

 

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

 

Duke is an Affirmative Action/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, sexual orientation, or veteran status.

 

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

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

Similar jobs