Data Management Clerk- Oncology Clinical Trials- Full Time

The Data Management Clerk is responsible for assisting the oncologist and trials team with all aspects of the Clinical Trials process. This includes collection and submission of patient data, monitoring study compliance, preparing correspondence and regulatory documents for ethics submission and sponsor study files. The Data Management Clerk is responsible for developing processes to ensure effective data flow and communication with various study sponsors.

Duties:

1. Coordinate with various internal and external departments to facilitate Clinical study related activities.
2. Extract accurate information from SAH charts or other source documents and completes and submits case report forms to Clinical Study Sponsor within specific timelines.
3. Monitor patient admissions, progress and disease status between protocol visits. Organize and prepare charts for physician protocol follow ups, monitor visits and audits. Enter data on multiple electronic report forms.
4. Liaise with Clinical Trials Coordinator, Clinic Nurses, and Oncologist to ensure necessary tests, scans, biopsies are booked and documented in the clinical chart.
5. Liaise with pharmacy for study drug re-supply to patients, orders and confirms study drug shipments. Verify all required tests are ordered and completed within protocol specific timelines.
6. Request and submit diagnostic imaging and pathology specimens to central radiology/laboratory facilities. Photocopy, fax and mail forms to study sponsors.
7. Maintain data collection in an organized fashion according to established procedures; Update and or correct existing data when necessary.
8. Maintain safety adverse event databases and submission of safety reports and regulatory documents to Research Ethics Board (REB).
9. Update and circulate all relevant study materials to clinic staff. Maintain all site regulatory documents and study files.
10. Arrange site monitoring visits and study initiation visits.
11. Meet with study monitor to review case report forms, source documentation and regulatory compliance. Ensure that every patient clinical trial chart is complete, accurate and secure.
12. Safeguard and release patient information under the provisions of Ontario Health Information Privacy Act and maintain clinical trial inventory.
13. Prepare lab kits for specimen collection including collection instructions for laboratory staff.
14. Handle, store and ship laboratory specimens to external laboratories following Dangerous Goods shipping and handling guidelines.
15. Screen patient charts to determine recommendation of eligibility. Create clinical trial chart.
16. Complete required training including:
    • National Institute of Health (NIH) certificate in ‘Protecting Human Research’
    • National Cancer Institute of Canada (NCIC) attendance at ‘Good Clinical Practice’ workshop
    • Transportation of Dangerous Goods training
    • Good Clinical Practice (GCP) and Tri-Council Policy Statement (TCPS2) training
17. Maintain subject recruitment and screening database. Develop patient calendar for follow-up schedule.
18. Other duties as assigned

Qualifications:             

• Diploma/degree in related discipline or equivalent experience (healthcare or research related)

Experience:

• Experience using multiple data sources to obtain and synthesize information
• Experience with research preferred
• Oncology experience preferred

Skills & Ability

• Oral and written communication skills to discuss and document research progress.
• Strong organization and interpersonal skills.
• Outstanding written, oral, and analytical skills
• Exceptional organizational skills
• Ability to work effectively and efficiently as a team member in a fast paced environment
• Computer literacy in a Microsoft environment including experience in the development of spreadsheets, Word, Power Point, Outlook, and Visio.
• Ability to organize time effectively to perform the duties of the position.
• Comfortable learning and working within multiple EMR systems Knowledge of and adherence to Hospital Standards of performance, and organizational policies and procedures. 
• Understanding of organization’s mission, vision and values.
• Ability to work independently, accurately, and to problem solve methodological issues that arise during the course of the research.
• Ability to apply sound research techniques, methodology, and logical critical analysis.
• Demonstrates proficiency with use of Microsoft Office suite applications including Excel and Access.
• Demonstrates knowledge and proficiency in use of Meditech Information Systems/ Mosaiq.
• Demonstrates working knowledge of basic computer equipment and multi-function devices.
• Displays strong initiative, establishing personal goals and taking responsibility for meeting them within defined timeline.

Note: Because of the changing nature of the work and work to be done, other responsibilities and duties may be assigned and qualifications may be adjusted from time to time. Only those selected for testing/ interview will be contacted.