• Job Description

  Req#: 240630
  School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation'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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

  Position Summary

  The CTC II develops, coordinates and implements the management of the clinical endpoint adjudication process for clinical trials research conducted by Principal Investigator(s) at the Duke University Medical Center. The CTC II also performs a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data. The Clinical Event Classification (CEC) Coordinator II is also responsible for the skills and responsibilities at the CEC CTC I level.

  ** NOTE: This is a remote position with the opportunity for individuals local to Durham, NC, to work on-site. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Connecticut; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia, Washington, or Washington, DC.

  Primary Responsibilities and Task

  • Review CRF to assure compatibility with CEC trial responsibilities

  • Depending on trial assignment, may coordinate the work of Clinical Data Assistants working on CEC aspects of the trial
  • Use MS Access or other software for purposes of status reporting or communicating trial issues with project team
  • Use Clinical Data Management software for tracking, running reports, or viewing CEC related data
  • Serve as a mentor to CTC I by welcoming questions, sharing work, delegating progressive responsibility, reviewing their work and providing constructive coaching and feedback
  • Make presentations to project teams and at investigator meetings
  • Prepare CEC trial start-up materials
  • Test trigger programming by manually reviewing appropriate percentage of first triggered cases
  • Identify clinical data criterion algorithm used to trigger suspected events
  • Define data integrity checks for event classification form
  • In collaboration with PL & CEC faculty and trial protocol identify events to be reviewed
  • In collaboration with PL & CEC faculty identify specific adjudication criterion for event classification
  • Triggers to identify suspected clinical events
  • Identify CRF variables/Data critical to the CEC process
  • Process document (EndPoint definition, roles & responsibilities, source docs)
  • Identify and communicate source documents and CRF data necessary for CEC
  • Inservice fellows
  • Perform review of adjudication to assure consistent application of endpoint definitions
  • Work Instructions
  • Train CDA’s, Trial team basic clinical training on CRF
  • Presentation at investigators meeting
  • Design EndPoint Classification forms
  • Choose and implement tracking system and process

  • Independently and consistently manage all aspects of CEC operations on multiple small clinical trials, or a large clinical trial including trials where the DCRI is collaborating with other organizations performing parts of the trial CEC process
  • Participate in close-out committee decision making regarding (CEC timelines) to trial completion, resolution of unresolved events
  • Other duties as assigned

  Other Duties

  Any travel up to 20% for CEC related activities as required inside and outside of the USA to accomplish responsibilities.

  Required Qualifications

  Education/Training:

  • Completion of RN/PA/Pharmacist training and 2 years healthcare experience; or allied health degree and 5 years healthcare experience; or advanced degree in public health/related field and 1-year clinical trials research experience; or BA/BS and 3 years clinical trials research experience.

  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 trials research; 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. 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.

• About the company

  Duke University is a private research university in Durham, North Carolina.

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