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Validation Engineer - Consent Forms/Clinical trials/Regulations 27.88-30 $/hr
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Posted:
21 Sep 2009
Apply Deadline:
17 Dec 2009
Location:
Mounds View, MN, USA
IMMEDIATE OPPORTUNITY in Minneapolis MN for a Clinical Research Specialist to work with a Worldwide Manufacturer of Medical Equipment. This is a contract position.
Responsibilities:
-> Reviews and approves center activation documents.,Work with the Clinical Study Manager to satisfy applicable regulatory standards
-> serves as the primary point of contact for a specified region/territory of research centers for actions relating to study subject informed consent form (ICF) and related ICF activities during IRB approval/renewals
-> This position will develop strong working relationships with this group of centers in order to accelerate center activation cycle time and foster strong customer partnerships
-> The Informed Consent Expert will partner with other internal Medtronic functions such as field personnel, contract analysts, study team members, and the Law Department to accomplish these goals
-> Acts as primary contact for assigned centers for any activities related to ICF's
Requirements:
-> Undergraduate Degree High School Diploma or Equivalent General Experience in a Clinical Study Research Environment:1 - 3 Years
-> Strong understanding of GCPs and Center Activation requirements
-> Strong knowledge of regulations in clinical testing
-> Proven strong customer interface skills and experience
-> Ability to identify and adapt to shifting priorities and competing demands
Benefits:
-> Paid Vacation
-> 401K
-> Health Insurance, and more...
Questions you will be asked:
• Do you have an Undergraduate Degree or High School Diploma or Equivalent and THREE Years minimum experience in a Clinical Study Research Environment. When and Where.
• Do you have a strong understanding of GCPs and Center Activation requirements? Describe.
• Describe your knowledge and experience with clinical testing regulations.
• Describe your knowledge and skill level of Medical terminology?
Related Words: clinical research specialist, consent forms, regulatory issues, clinical trials, astd, american society for training and development, american society of training and development, trainer, instructor, instructed, instructional design, course developer, course design, develop train, developed courseware, training manager, manager training, instructor staff, developed instructional design, project administrator, project plans, progress reports, weekly billings, billing reports, project 98, project administration, project file, time constraints, project task, assign resources, manage resource, task list, milestones, project baseline, managing tasks, link tasks, recurring task, task constraints, split tasks, assigning resources, define resources, resource pool, workloads, project flow, work assignments, monitoring, reporting, tracking, deadline, planning, forecasts, resource utilization, tracked project, manpower requirements, feasibility studies, project accounting, expense tracking, managed resources, tracked progress, cost analysis, assigned tasks, allocated hours, gnatt, pert, cpm, gert, project life cycle, wbs, work breakdown structure, project plan, project stages, project requirement, project implement, cost control system, project implement, project basis, critical path, labor costs, billings, pre-bid meetings, subcontractor meetings, project controls
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