Provide non-medical support to clinical research studies by actively participating in the documentation of clinical trial data.
Work under the direction of the Supervisor, Data Entry to conduct study-specific data entry
Direct data entry from study specific source documents
Complete Case Report Forms (CRFs) / electronic Case Report Forms (eCRFs)
Respond to and resolve queries with in specified timelines
Perform data verification activities
Document data discrepancies
Assist in testing the study database
Update CRF entry completion logs as required
File SMS results, labs, waivers
Photocopy labs / ECGs as required by data entry requirements
Other duties as assigned
Skills & Attributes
Ability to carry out tasks in compliance with GCP, ICH, regulatory and organizational standards as required
Understanding of clinical trial protocol
Good time and project management skills
Proficiency in computer software programs (e.g., Word, Excel, Power Point)
Excellent computer keyboard skills and use of web resources
Ability to work independently as well as with others
Excellent communication skills
Critical thinking and problem solving
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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