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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary

***This is a 32 hour a week position***

The CEC CTC I is responsible for performing clinical review of events and coordinating and implementing the management of clinical event adjudication processes.

This work is done for Phase I, II, III, IV, trials and other clinical research endeavors conducted by principal investigators at the Duke Clinical Research Institute (DCRI). The efforts include assisting with the development, coordination and implementation of research and administrative strategies essential to the successful management of clinical trials research conducted by principal investigator(s) at DCRI. The CTC I must perform a variety of duties involved in the organization, oversight, documentation and compilation of clinical research data.

** 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

There are three CTC levels. Each CTC level is responsible for the job responsibilities at that level as well as the responsibilities for the CTC levels below it.

The CTC I position works under the guidance of a CTC II or CTC III to plan conduct and report all or part of the clinical event component of a clinical trial.

Primary Responsibilities and Task

* Maintain familiarity with trial protocol, procedures, and clinical endpoints.

* Maintain CEC documentation including the CEC Process Document, Work Instructions, CEC review form, triggers, reports.

* Review source documents for clinical events to identify information required for adjudication.

* Classify clinical events based on source documents and other clinical data, according to predefined criterion.

* Resolve queries and questions from data management and statistician on data entered Event Classification Review forms.

* Identify inconsistencies between reviewers and provide feedback to reviewers.

* Provide feedback to programmers and trial team on usefulness of reports and communicate recommendations for improvement.

* Formulate recommendations for trial decisions involving CEC.

* Collaborate with project team to make decisions about trial operations and anticipate outcomes and affects.

* Create and adjust timelines for CEC process and deliverables.

* Utilize reports to monitor the CEC process and communicate progress.

* Arrange adjudication meetings for clinical event review.

* Work with department managers to assure that resources are optimally utilized.

* 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: (refer to the Duke HR website for minimum qualifications required if applicable)

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

* One-year experience must be in clinical research or allied health care with exposure to clinical research. Experience using spreadsheet and word processing software is also required

Minimum Qualifications

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 one year 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 three years healthcare experience; or Associates degree(non-specified) plus a minimum of four years closely related clinical research; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with no additional experience; or 3. Completion of a Bachelor's degree plus a minimum of one year directly related clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of two years closely related research experience. **State of North Carolina licensure 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.