Opening for Clinical Data Coordinator @ ICON Clinical Research - Chennai, Tamil Nadu D2 Opening for Clinical Data Coordinator @ ICON Clinical Research - Chennai, Tamil Nadu This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. A Clinical Data Coordinator under the supervision of more experienced Data Management Personnel and in accordance with project specific timelines 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 (ICH) Guidelines, and all applicable laws and regulations Overview of the role Recognize, exemplify and adhere to ICONs 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 Role Requirements Bachelors degree or local equivalent in a scientific discipline and/or appropriate experience 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 Click here to apply
Posted on: Fri, 23 Jan 2015 09:27:07 +0000