CLINICAL TRIALS PROJECT LEADER I

DUKE JOB DESCRIPTION: Clinical Trials Project Leader I

DCRI Position Description: Outcomes Project Leader I

OCCUPATIONAL SUMMARY: 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.

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.

Travel may be required but is expected to be minimal.

** NOTE: 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, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.

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 staff, supports and contributes to the administrative processes for the 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:

• Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.
• 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 Outcomes 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 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.
• 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;
  • PCORnet Common Data Model;
  • 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;
  • Codelist development and maintenance;
  • 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, 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.

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.

REQUIRED QUALIFICATIONS AT THIS LEVEL

Education/Training: 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, Radiological Technology, Licensed Practical Nurse) 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

Skills: N/A

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

Degrees, Licensures, Certifications

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