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CLINICAL TRIALS PROJECT LEADER I, DCRI, Outcomes (Durham, NC, US, 27710) @ Duke University

Durham, NC, US, 27710OnsiteFull-time
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School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation&apos;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.<p> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">OCCUPATIONAL SUMMARY: </span></strong><span style="font-size:12.0pt">The Outcomes 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, and health service policy projects. The Outcomes Project Leader I 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 applied clinical and policy research. This individual 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. </span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">The Outcomes 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 Project Leader. These projects will typically utilize real-world data and operate under constraints of time and resources. The Outcomes Project Leader will also contribute to the management of real-world data networks (e.g., PCORnet, CardioHealth Alliance) and will be knowledgeable of the governance and expectations of each.</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:12.0pt;font-family:'Times New Roman', serif"><span style="font-family:Aptos, sans-serif">** NOTE: <span style="color:black;background-color:white">This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, </span>Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Travel may be required but is expected to be minimal.</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">WORK PERFORMED</span></strong></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Administrative Management:</span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Includes supervisory responsibility for assigning work to others, reviewing completeness &amp; accuracy of work of others, giving recommendations, advice, or guidance to others</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Manages staff, supports and contributes to the administrative processes for the group and overall department.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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. </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Provides service-oriented support to other functional sub-groups, departments and project teams.</span></li> </ul> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Project Leadership: </span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Participate in industry initiatives; i.e. technical and process standards development, professional society administration, industry related certification programs and conference planning and delivery.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Capture experiences and lessons learned as routine part of project lifecycle.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Create routine mechanisms for informatics and Outcomes issues to be collected and communicated on project teams.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Manage internal and external customer expectations.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Identify and ensure compliance with regulations and policies.</span></li> </ul> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Technical: </span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Lead functional group 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-disciplinary team.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Understand and represent the user perspective when designing technical solutions, facilitate and enhance the discussions with clinical and technical teams.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Develop and maintain expertise in the following</span></strong><span style="font-size:12.0pt">: </span> <ul style="list-style-type:circle;margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Electronic health records and health information organizations: CMS and other peer data structures;</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">PCORnet Common Data Model;</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Best practices in utilizing and linking data sources and assessing data quality; </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Statistical principles and consideration for clinical data management; </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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; </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Codelist development and maintenance; </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Relational and/or analytical database design, programming language(s), data transfer and query methods, especially in distributed data networks.</span></li> </ul> </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Perform technical support tasks: problem space analysis, writing specifications, data modeling, programming, systems testing, and troubleshooting as needed.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Consult on or provides direct support for complex research efforts with significant health services research components across the Duke community and collaborators.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Identify and support the development, adoption and use of tools, templates and best practices across projects.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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.</span></li> </ul> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Training: </span></strong></p> <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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. </span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Develop and conduct training sessions for internal and external staff on a regular basis; present at conferences and/or publish in peer reviewed journals.</span></li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Contribute to department training and development infrastructure</span></li> </ul> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt"> </span></strong></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">Perform other related duties incidental to the work described herein.</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. </span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">REQUIRED QUALIFICATIONS AT THIS LEVEL</span></strong></p> <p style="text-align:justify;margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Education/Training: </span></strong><span style="font-size:12.0pt">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:</span></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;text-indent:-0.5in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiological Technology, Licensed Practical Nurse) plus a minimum of five years’ healthcare experience; or</span></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;text-indent:-0.5in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">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 </span></p> <p style="margin:0.0in 0.0in 0.0in 0.5in;text-indent:-0.5in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">3. Completion of a bachelor’s degree plus a minimum of three years directly related experience in clinical trials research; or</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt"> 4. Completion of a bachelor’s degree plus a minimum of four years’ closely related research experience. </span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">** State of North Carolina license may be required**</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="text-align:justify;margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Experience: </span></strong><span style="font-size:12.0pt">None required beyond that described above. </span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><span style="font-size:12.0pt">OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt">Skills: </span></strong><span style="font-size:12.0pt">N/A</span></p> <p style="margin:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif"><strong><span style="font-size:12.0pt"> </span></strong></p> <h3>Minimum Qualifications</h3> <p> </p> <h3>Education</h3> <p>Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician&apos;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&apos;s degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a Master&apos;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&apos;s degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a Bachelor&apos;s degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**</p> <p> </p> <h3>Experience</h3> <p>None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE</p> <p> </p> <h3>Degrees, Licensures, Certifications</h3> <p>None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE</p><br> <br> <div><p> <strong>Anticipated Pay Range:</strong> Duke University provides an annual base salary range for this position as USD $86,714.00 to USD $140,129.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate&apos;s work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. </p> <br> <div><p> Your total compensation goesbeyond 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/ </p> <br> <div><p> <strong>Equal Opportunity Employer:</strong> Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual&apos;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. </p> <br> <div><p> Duke aspires to create a community built oncollaboration, 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. </p> <br> <strong>Essential Physical Job Functions:</strong> <div> 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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [email protected]; phone: 919-668-1267). <br></div></div></div></div></div>

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