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Occupational Summary

This position is for a Clinical Research Associate (CRA) who will serve as the site management team lead for a large, international pediatric observational registry. The CRA will provide day-to-day oversight and direct the project work of the site management team (comprised of a project assistant, two project coordinators, and one regulatory coordinator) in addition to working directly with sites to resolve queries, data quality issues, and ensure administrative and documentation standards are met.

The CRA will also work closely with project leadership (Principal Investigator, Project Leader, and Registry Operations Lead) to ensure all of the registry’s active projects are on track to meet timelines and deliverables as promised to the sponsor and to implement changes to the registry on an ongoing basis. This includes but is not limited to: adding new registry cohorts (i.e. disease groups), registry sub-

Work Performed

• Serve as a source of escalation for issues raised by the clinical sites and work with the appropriate parties within DCRI and or the sponsor to resolve questions and issues in a timely manner
• Work closely with the Registry Operations Lead to identify key process changes and implement additional remote data monitoring procedures as applicable
• Coordinate the development of protocol amendments (including informed consent changes) and standard operating procedures for ongoing monitoring of the registry sites
• Ensure the project’s Trial Master File (TMF) is kept up to date and inspection ready
• Conduct virtual and in-person site visits for the purposes of providing additional training to struggling sites
• Provide feedback to sites who have demonstrated deficiencies and created corrective action plans as needed
• Implement and conduct remote site monitoring activities to ensure the integrity of the registry’s data
• Serve as direct line manager of team member(s) as needed
• 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.

Preferred Skills:

• Detail oriented
• Excellent written and verbal communication skills
• Ability to multi-task and manage multiple competing priorities

• Ability to quickly re-prioritize with the team when timelines are modified or when new/immediate tasks are added
• Prior experience working as a site manager for a multi-site study
• Working knowledge of IRB submission processes and regulations
• Prior supervisory experience

Work requires graduation from. an accredited degree program providing

1. Completion of an allied health degree (e.g., Respiratory Therapy, 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: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of four 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 two years directly related experience in clinical trials research; or

4. Completion of a bachelor's degree plus a minimum of three 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.