CLINICAL RESEARCH ANALYST


diversity employer



CLINICAL RESEARCH ANALYST
Duke Office of Clinical Research

Occupational Summary
Review new studies submitted in the eIRB to determine whether a build in Maestro Care is necessary and will work to facilitate study set-up within the DOCR study tracking REDCap database. Review study documents to complete a research charge router and meet with study teams to review the charge router prior to the study being built in Maestro Care. Ensure ClinicalTrials.gov registration and reporting compliance as well as any training compliance for study team members, as needed. Assist with implementation of new institutional systems, including OnCore.

Work Performed
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, ePRMS need) and coordinates the multi office work; ensures compliance with Human Subjects Research training and ClinicalTrials.gov registration and results reporting requirements.

This process currently entails:
1) Reviewing study documents to identify research-specific clinical activities and appropriate billing designations, including qualifying trial status

2) Drafting research charge routers, which are used as the basis of the Maestro Care order set and billing calendar

3) Meeting and communicating with study teams to clarify and validate these assessments

4) Directing PRMO, investigational pharmacies, and the Maestro Care build team in the construction of these components

5) Tracking the build process until the requirements for DOCR approval have been met

6) Work with the OnCore project team to implement replacement workflows for the above tasks

Activate studies in eResearch at the time of full institutional approval.

Support Clinical Research Units in the administration of Duke-as-a-site clinical research and serve on committees dealing with research-related issues.

Assist in the coordination and implementation of new institutional tools and applications. Serve as a liaison with the PRMO Clinical Trials Billing Office, identifying best practices and overseeing resolution of complex research billing issues.

Assist study teams with entering registration and results information in ClinicalTrials.gov. Track studies for compliance with clinical trials disclosure regulations and policies.
Assist in the development of Policies for the Governance of Clinical Research Activities of Duke.

Supervisor
This position reports to the Director, Research Operations.


Requisition Number
401291582

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1101 CLINICAL RESEARCH ANALYST

Job Family Level
12

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, 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.

Education

Work requires graduation from an accredited degree program in a clinical field such as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two years of 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 five years clinical and/or research experience; or 2. Completion of a bachelor's degree in a field related to health science and a minimum of three clinical and/or research experience.

Experience

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

Auto req ID

91743BR

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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