QA & REGULATORY COMPLIANCE ASSOC

Location
Durham, NC
Posted
Jun 14, 2018
Institution Type
Four-Year Institution

diversity employer



QA & REGULATORY COMPLIANCE ASSOC
Duke Office of Clinical Research


General

Coordinate DOCR's portion of the clinical research Institutional Approval process. Review study documents to complete required start-up build in OnCore and meet with study teams to review the billing grid prior to the study orders and Beacon builds for Maestro Care. Collaborate with teams internal and external to DOCR to assess study readiness prior to go-live. Provide clinical guidance and training to Clinical Research Analysts regarding protocol interpretation and billing grid creation.

Primary Duties and Responsibilities:
  • Be a Subject Matter Expert in the institutional study initiation process and DOCR study approval.
  • Create and enhance an institution-wide study start-up training; conduct workshops/training sessions for faculty/staff/administration regarding the study start-up process.
  • Help with oversight of build assignment and metrics for research order sets and Beacon research treatment plans. Maintain REDCap database for tracking build and responsible for the DOCR Support Service Now queue.
  • Review amendment and correction requests received through Service Now and DOCR-Startup, and coordinate with PRMO and the Research Maestro Care build team to make the appropriate changes in OnCore and Maestro Care (if applicable).
  • Field questions from the research community about OnCore, Maestro Care and the DOCR review process.
  • Review new studies in the DOCR approval queue in eIRB and OnCore (when in production). Assess and studies for operational needs (OnCore, Maestro Care builds) and coordinates the multi office work.
  • Serve as a liaison with the PRMO Clinical Trials Billing Office, identifying best practices and overseeing resolution of complex research billing issues.
  • Collaborate with teams inside and outside of DOCR to assess study readiness to go-live.
  • Identify studies requiring additional Maestro Care workflow/Study Planning support and refer these teams to the appropriate support resources.
  • Provide guidance and training to Clinical Research Analysts regarding protocol interpretation and billing grid creation.
  • Draft the majority of research billing grids for pediatric oncology studies.


Supervisor
This position reports to the Associate Director, Maestro Care for Research.

Requisition Number
401413528

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2766 QA & REGULATORY COMPLIANCE ASSOC

Job Family Level
14

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 generally requires a bachelor's degree in a biological Science.

Experience

Work requires six years of experience quality assurance or quality control related to clinical trials. A Master's degree in a related field may be substituted for 2 years of required experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Preferred:
At least 2 of the years of clinical experience to include Super User-level usage of Epic software.


Auto req ID

100139BR

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.

PI102926315

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