Clinical Research Associate II

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Location
New Hope, MN
Job Type
Direct Hire
Date
Dec 07, 2017
Job ID
2548633

GR Identifier: $Medd


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The Clinical Research Associate II (CRA II) is responsible for conducting the day-to-day management of activities associated with the execution and monitoring of high-quality clinical trials for the company’s products. The CRA II ensures that clinical tasks are being performed in compliance with applicable regulatory standards, Good Clinical Practices, and company policies and procedures.

Responsibilities

  • Assist in the planning and execution of clinical studies ensuring that deliverables are completed on time and within budget
  • Create and manage reports that detail the clinical study progress such as subject screening and enrollment, data collection, documentation of adverse events, and payments
  • Assist with the development and management of study-related documents and materials such as investigational plans, case report forms, study manuals, monitoring plan, informed consents, websites, recruitment materials and other study related tools
  • Participate in site qualification and site initiation process, including review of required site documentation
  • Conduct training of investigators and coordinators
  • Coordinate and conduct monitoring visits at investigative sites to ensure compliance with the investigational plans, regulations, and timely receipt of data, including source document verification, device accountability, and writing of monitoring visit reports
  • Verify appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
  • Management of investigative sites to ensure sponsor support of trial activities and oversight of site compliance
  • Assist with the development and implementation of site corrective actions as needed to address any noncompliance issues
  • Assist in planning, preparing, and presenting materials for investigator and coordinator meetings
  • Assist with vendor management to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
  • Participate in regular project team meetings
  • Develop and maintain current working knowledge of the disease state & product
  • May assist clinical manager by providing input to sections of clinical reports for FDA (510(K), IDE/PMA) and abstracts/manuscripts

Basic Qualifications

  • BA/BS or equivalent medical / industry experience
  • Minimum of 2+ years experience directly supporting Clinical Research
  • Strong computer skills with a proficiency with MS Windows-based applications
  • Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, ISO 14155, and current industry practices related to the conduct of clinical trials
  • Excellent communication skills (oral and written)
  • Strong organizational skills and able to manage multiple tasks
  • Ability to work independently
  • Previous experience with peripheral vascular devices preferred
  • Previous experience with EDC systems preferred
  • Ability to work effectively in cross-functional teams preferred
  • Demonstrated ability to work effectively in cross-functional teams
  • Valid driver’s license required
  • Able to travel 20% on average and up to 50% during peak periods

Education and/or Experience

  • BA/BS or equivalent medical / industry experience
  • Minimum of 2+ years experience directly supporting Clinical Research