Clinical Trials Coordinator II, Dcri CEC

Duke University Durham , NC 27701

Posted 3 months ago

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational 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.

Responsibilities

  • 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

Travel

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

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.

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh

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Clinical Trials Coordinator II, Dcri CEC

Duke University