Clinical Data Coordinator III
Clinical Data Coordinator III
Location – Any US Location
In accordance with project specific timelines, perform data management activities to ensure the generation of accurate, complete and consistent clinical databases. To assist with the training of less experienced Clinical Data Coordinators.
Overview of the Role
Role Requirements / Skills / Experience Required
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures.
- Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
- Complete all assigned training (Including the Study Lead Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.
- Record all billable and non-billable time in the appropriate timesheet management system.
- Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks.
- Perform external data reconciliation.
- Perform Serious Adverse Event reconciliation.
- Generate and close/resolve (as appropriate) data queries.
- Freeze and/or lock eCRFs (as appropriate) within the Electronic Data Capture System.
- Create and maintain study files and other appropriate study documentation.
- Perform User Acceptance Testing and collaboratively work with CDMS personnel to see issues found through re-testing and resolution.
- Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.
- Train and guide less experienced CDCs in data management requirements and activities.
- Perform other project activities as required in order that study timelines are met (for example, filing and archiving of study documentation, dispatching of queries to investigator site for resolution, etc.)
- As required; communicate effectively with the project team, Study Lead, Project Lead and Project Manager.
- Act as a mentor to junior level staff.
- Bachelor’s degree or local equivalent in a scientific discipline and/or appropriate experience.
- A minimum of 2 year relevant clinical research industry experience
- Excellent written and oral communication skills
- Excellent accuracy and attentiveness to detail
- Ability to work within a team environment
- Excellent interpersonal skills
- Knowledge of database technologies and processes
- Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.
Working for ICON you will be provided with an excellent benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON.
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
US-Any US location
US-Chicago, US-Durham, US-San Antonio, US-Dallas, US-Atlanta, US-Sugar Land, US-Hanover, US-Brentwood, US-Lake Forest, US-Newark, US-North Wales, US-New York City, US-Austin
09/May/13, 3:19:38 AM
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