| RegulatoryCareers.com | |||
| Jobs Index - Index of recent job listings. | |||
| Resumes Index - Index of recently posted resumes. | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| |||
| Clinical Data Associate III CA Open (J#45618) Title: Clinical Data Associate III Company: Alere Job Description Summary The purpose of this position is to perform as clinical data management representative on one or more clinical teams. This position will involve assisting the Supervisor, Clinical Data Management, by acting as Lead Data Manager for one or more studies working with little or no supervision from study start-up through database lock. This role will also include providing support to Clinical Data Management personnel with various functions within the data management team. Tasks and responsibilities: - Serve as Lead Data Manager performing the following functions with little or no supervision for multiple studies: - Tracking and scanning of incoming CRFs and perform 1st and 2nd pass data entry. - Review protocols of upcoming studies and initiate CRF creation, development of clinical database and validation of activated CRFs. - Provide clinical with CRF Completion Manual instructions for distribution to sites. - Write Edit Check document, create test patients and perform validation of Edit Checks. - Conduct query generation and data modifications throughout study. - Provide various reports to clinical regarding study status to include printing queries, Missing Pages Reports, Query Status Reports, etc. - Resolve queries, generate proper documentation i.e. Data Conventions, and collect appropriate documentation i.e. Notes-to-File throughout the course of a study. - Conduct audits of clinical database vs. CRF data and write Audit Report upon completion of study. - Initiates preparation for database audit and database lock procedures. - Utilizes computer software to accurately and efficiently input and verify clinical data on an as needed basis. - Provides data entry training of new employees, including temporary data entry personnel. - Creates and updates departmental documentation including but not limited to training and entry guidelines, SOPs, and procedural work flows. - Attends internal and external meetings and/or seminars. - Strong team interaction between Clinical Data Management, Clinical Trials Monitoring, Medical Affairs, Regulatory Affairs and Information Services. - Demonstrates commitment to the development, implementation and effectiveness of Alere s Quality Management System per ISO, FDA and other regulatory agencies. - Perform other duties as needed. More... | |||
| RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs | |||
| RegulatoryCareers.com is the premier job search website focused specifically on the employment needs of Regulatory Affairs Companies and Professionals. Use this as an exclusive resource to find your next job or employee. We guarantee that you will be pleased with the special focus of this web site. | |||