Clinical Data Coordinator

Talent Acquisition Team Lead
About the role
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JOB TITLE: Clinical Data Coordinator I
REPORTS TO: Data Management Project Lead, Data Management Project Manager
SECTION 1: POSITION SUMMARY
Under supervision of more experienced Data Management Personnel and in accordance with
project specific timelines, to perform basic data management activities to ensure the generation
of accurate, complete, and consistent clinical databases. To fulfill his/her job responsibilities in
accordance with Good Clinical Practices (GCPs), ICON Standard Operating Procedures (SOPs),
Working Procedures (WPs), Study Specific Procedures (SSPs), International Committee on
Harmonization Guidelines, and all laws and regulations.
SECTION 2: JOB FUNCTION / RESPONSIBILITIES
'Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
• '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
• Travel (approximately 0%) domestic and/or international
• '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 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 (e.g.
Planview™)
• 'Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and
manual data checks
• '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
• 'Participate in User Acceptance Testing under supervision of the Study Lead
• 'Perform Quality Review of clinical data
• 'Perform other project activities as required in order to ensure that study timelines are met (for
example, filing and archiving of study documentation, dispatching of queries to investigator sites for
resolution, etc.) .
• 'As required, communicate effectively with the project team, Study Lead, Project Lead and Project Manager.
SUPERVISION
• N/A
SECTION 3: EXPERIENCE, SKILL, KNOWLEDGE REQUIREMENTS.
• To perform this job successfully, an individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability
required. Reasonable accommodations may be made to enable individuals with disabilities to perform
the essential functions.
• Prior Data Management experience preferred
• Strong written and oral communication skills
• Ability to work within a team environment
• Excellent interpersonal skills
• General computer literacy. Knowledge of database technologies and processes is a plus
• Knowledge of medical terminology is a plus
SECTION 4: EDUCATION REQUIREMENTS
• Bachelor's degree or local equivalent in a scientific discipline and/or appropriate experience
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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