Position Summary

The Clinical Event Classification (CEC) Coordinator II develops, coordinates and implements the management of the clinical endpoint adjudication process for clinical studies performed within CEC. The CTC II is also responsible for mentoring other CTC personnel to achieve success within CEC and to work with the Project Leads to develop and update processes, SOPs and working practice documents for CEC. The CTC II is also accountable for the skills and responsibilities at the CTC I level.

** 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.

Primary Responsibilities and Task

• Demonstrate in-depth knowledge of study protocols, relevant SOPs and clinical endpoints through accurate, timely and efficient management of CEC events with proven ability to effectively support study start-up and routine study activities. Effectively conveys CEC Study knowledge as requested for training of team members and new employees
• Prepares presentations of CEC related study activates, including endpoint definitions and review process, for project teams and investigator meetings. Coordinates the work of CEC team members working on CEC aspects of the trial to ensure accurate and timely classifications of clinical events based on source documents and other clinical data, according to study specifications and SOPs. Effectively and efficiently resolves queries and questions from study team relative to CEC data. Manages and review process to ensure adherence to study specifications, including resolution of reviewer inconsistencies.
• Reviews CRF/eCRF to assure congruence with CEC Study protocol and endpoints specifications. Identifies and works to resolve issues that place data integrity at risk. Ensures team members receive and documents study specific training. Coordinates CEC aspects of interim analyses, and trial close out, providing input to report development, reviewing for accuracy and appropriateness to purpose.
• Applies proactive approach to identify, escalating as needed, potential study risks and quality concerns. Responsible for study adherence with quality, compliance and SOP standards. Provides input to management of project budgets and forecasting as well as review of scope of work and tasks.
• Demonstrates the ability to review data sets to identify unreported potential endpoints and serious adverse events.

Other Duties

• Other duties as assigned
• Perform other related duties incidental to the work described herein.
• Any travel up to 20% for CEC related activities as required inside and outside of the USA to accomplish responsibilities.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Required Qualifications

Education/Training: (refer to the Duke HR website for minimum qualifications required if applicable)

Completion of RN/PA/Pharmacist training and 2 years healthcare experience; or allied health degree and 4 years healthcare experience; or advanced degree in public health/related field and 1 year clinical trials research experience; or BA/BS and 2 years clinical trials research experience.

• Preferred Experience: One year should be in directly related to CEC position or safety. Experience with and creating detailed oriented work instructions. Experience using multiple databases, spreadsheets, and word processing software.

Experience:

• OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE

Knowledge, Skills and Abilities:

• Strong technical spelling and grammar skills
• Ability to write and speak clearly and concisely in a variety of communication settings and styles
• Strong interpersonal skills; ability to establish and promote positive business relationships; customer service oriented
• Ability to collaborate with study staff and internal and external partners to achieve goals
• Proficient computer skills including use of MS Office Suite (Word, Excel, PowerPoint) and enterprise project management systems
• Strong organizational skills and attention to detail
• Ability to prioritize activities effectively to accomplish individual and team goals with competing deadlines
• Strong problem analysis and resolution skills
• Ability to perform routine site management and monitoring activities independently
• Working knowledge of medical terminology
• Working knowledge of FDA and NIH regulations
• Working knowledge of site management and clinical

Registration, Certification or Licensure:

• Registered Nurse Preferred, but not required
• ACRP CCRC or SoCRA CCRP preferred

Minimum Qualifications

Education

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 Pharmacists plus a minimum of two years 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 a minimum of one year directly related clinical trials research experience; or 3. Completion of a Bachelor's degree plus a minimum of two years directly related clinical trialsresearch; or 4. Completion of a Bachelor's degree plus a minimum of three years closely related research experience. **State of North Carolina licensure may be required**

Experience

None required beyond that described above. ORAN 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.