CLINICAL TRIALS COORDINATOR I

Location
Durham, NC
Posted
Oct 03, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL TRIALS COORDINATOR I
DCRI - Clinical Events Commitee

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.
  • 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.
  • Coordinate the tracking, event processing and case preparation work done by Clinical Data Assistants (CDAs) performing CEC work.
  • Coordinate and oversee activities of CDAs performing CEC work.
  • Provide feedback and constructive suggestions to CDA's, performing CEC work Identify inconsistencies or discrepancies in triggers and reports.
  • 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 and CDA's to assure that resources are optimally utilized.

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.

Requisition Number
401286039

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1941 CLINICAL TRIALS COORDINATOR I

Job Family Level
79

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University 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 essential job 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.


Education

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN). Physician's Assistant (PA) or Pharmacists plus one year 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 in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; 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**

Experience

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

91529BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

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