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 Outcomes Clinical Trials Project Leader II develops, coordinates, and implements research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; performs a variety of duties involved in the organization, documentation and compilation of clinical research data; and functions in preceptor capacity for Clinical Trials Project Leader I's.

** NOTE: This position can be done remotely for candidates who live in the following states: NC, CA, FL, GA, MD, NY, SC, TN, TX, VA, AND WASHINGTON, DC **

WORK PERFORMED

Project Management & Problem Resolution:

• Recommend guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols.
• Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract development.
• Innovates and adapts research processes and guidelines including designs, methods and data, attending especially to innovations in research network and registry management, developing improvements in processes to increase efficiencies.
• Consistently provides new perspectives to issues
• Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.
• Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
• Anticipates and addresses simple or complex operational problems at any study phase.
• As part of the problem solving process, recognizes and considers the long-term benefits, risks and consequences of different solutions to the project and other project team members (including sub-study personnel, sponsors and subcontractors).
• Recognizes when issues need to be escalated to senior management in a timely manner. Proposes resolutions and leads these initiatives with assistance as needed.
• Demonstrates a flexible and adaptable problem-solving approach to the operational needs of projects and all project team members (including sponsors and subcontractors).

Team Management:

• Coordinate and lead the work of the Project Leader I staff and research team and provide feedback to staff's supervisor on a routine basis; conduct cross functional research team meetings as needed.
• Consistently recognizes the contributions of other team members.
• Exhibits inclusive approach to decision-making and goal setting processes.
• Fosters group ownership of and enthusiasm for project.
• Assigns specifics tasks in order to challenge team members while encouraging professional growth. Follows-up routinely with feedback and encouragement.

Financial Management:

• Proactively finds operational efficiencies in order to increase return on sales.
• Proactively forecasts and changes resource utilization according to project needs and to ensure efficient personnel utilization.
• Independently interprets and acts upon project-specific financial reports.
• Considers financial implications of different decisions and operational strategies.

Communication and Organizational Leadership:

• Appropriately exhibits persuasive communication skills to enhance the likelihood of building commitment and buy-in.
• Establishes, builds, and fosters relations with influential decision makers both internal and external.
• Conveys difficult information diplomatically.
• Exhibits ability to adapt communication style and approach to circumstances, particularly when addressing concerns or proposing a solution.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work 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. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Preferred Skills & Experience: Working knowledge of pragmatic and RWE-based research principles and best practices preferred for Outcomes Project Leaders.

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.

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three 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 Associates degree inClinical Trials Research related curriculum plus a minimum of six years healthcare experience; or

2. Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or

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

4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.

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

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.