CLINICAL TRIALS PROJECT LEADER I, DCRI PHSR
Duke University

Durham, North Carolina

Posted in Retail


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Job Info


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.

OCCUPATIONAL SUMMARY:

The Pragmatic Health Systems Research (PHSR) Project Leader I position provides leadership to the department and to projects for application of information technology and health services research data management. This includes identifying research and business objectives and informatics solutions utilized in clinical research and health services data management operations. This can include translational, clinical research, health service policy projects. The PHSR Project Leader has knowledge of biomedical informatics practices including medical computing, terminology, healthcare and research data systems and health information exchange, including the use of electronic health data, including claims data, in clinical and policy research. Oversees assigned projects and is active in developing more efficient and effective data management support for research projects supported by the department. Close collaboration with other functional areas within department and across Duke, and external organizations is necessary.

The (PHSR) Project Leader I typically leads the operations on one or more biomedical or policy research projects of average to moderate complexity, at times with oversight of a more senior (PHSR) Project Manager.

Travel is required.

WORK PERFORMED

Administrative Management:

  • Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others
  • Manages (PHSR) staff, supports and contributes to the administrative processes for the (PHSR) group and overall department.
  • Holds responsibility for and provides technical, fiscal, and management oversight for assigned projects and tasks. Projects may be of moderate complexity or pieces of larger projects managed by a higher level Project Manager.
  • Provides service-oriented support to other functional sub-groups, departments and project teams.

Project Leadership:

  • Provides leadership on behalf of the project and organization to ensure success of Duke's research endeavors.
  • Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.
  • Responsible for assuring that timelines, costs and deliverables of (PHSR) projects are well managed. This will often require external relationships and managing subcontracts.
  • Contribute to business development activities for (PHSR) projects such as presentations to prospective sponsors, development of scope of work, contract assumptions and cost estimates.
  • Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements
  • Participate in industry initiatives; i.e. technical and process standards development, professional society administration, industry related certification programs and conference planning and delivery.
  • Capture experiences and lessons learned as routine part of project lifecycle.
  • Create routine mechanisms for informatics and PHSR issues to be collected and communicated on project teams.
  • Manage internal and external customer expectations.
  • Identify and ensure compliance with regulations and policies.

Technical:

  • Lead (PHSR) activities supporting research projects, including: requirements and product evaluation, system design and customization, data structure design, technical specifications and associated documentation. Often this includes leading a cross-discipline team.
  • Understand and represent the user perspective when designing technical solutions, facilitate and enhance the discussions with clinical and technical teams.

  • Develop and maintain expertise in the following:
  • Electronic health records and health information organizations: CMS and other peer data structures;
  • Best practices in utilizing and linking data sources and assessing data quality;
  • Statistical principles and consideration for clinical data management;
  • Terminology and coding dictionaries and procedures used in healthcare delivery and research, and understanding of emerging tools and technologies; and understanding of emerging tools and technologies.
  • Relational and/or analytical database design, programming language(s), data transfer and query methods, especially in distributed data networks.
  • Focus on efficient and easily adopted methods for integrating different types of data (i.e. clinical data, administrative data, payment data, bio-specimens, and novel data sources) across systems or organizations.
  • Perform technical support tasks: problem space analysis, writing specifications, data modeling, and programming, systems testing, and troubleshooting as needed.
  • Consult on or provides direct support for complex research efforts with significant health services research components across the Duke community and collaborators.
  • Identify and support the development, adoption and use of tools, templates and best practices across projects.
  • Identify and produce resolution to common problems including appropriate people to ensure successful resolution and take steps to reduce potential for recurrence on this or other projects.
  • Training:

    • Educate internal and external partners on the value, role and methodology provided by pragmatic health services research, including use of electronic health record, payer and site and patient-reported data for use in clinical and policy research.
    • Maintain working knowledge of value and best-practices biomedical informatics, electronic health records, CMS and healthcare payer data, patient-reported data, and health services research.
    • Develop and conduct training sessions for internal and external staff on a regular basis; present at conferences and/or publish in peer reviewed journals.
    • Contribute to department training and development infrastructure

    Perform other related duties incidental to the work described herein.

    Minimum Qualifications

    Education

    Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of healthcare experience, or one of the following equivalents:

    1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associate's degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or

    2. Completion of a Master's degree in Public Health, Health Administration or a related area with one year directly related Clinical trials research experience; or

    3. Completion of a Bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or

    4. Completion of a Bachelor's degree plus a minimum of four years closely related research experience.

    **State of North Carolina license may be required.**

    Experience

    None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

    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.


    This job has expired.

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