Regional CRA - Medical Devices

Regional CRA - Medical Devices
  • Competitive
  • Permanent
  • Mason OH, US Mason WARREN US
Job Ref: JO000130704
Sector: Clinical
Sub-sector: Clinical
Date Added: 05 May 2022

Medical Devices – Sr. CRA

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.

The Sr. CRA will assist in the development, implementation and execution of study protocols and associated study documents for clinical trials and marketing studies, with primary emphasis on monitoring oversight of IDE clinical trials, including development of monitoring plans and review of all monitoring reports. The Sr. CRA will assist in the clinical monitoring, including the coordination of site activities from site start-up to site closure as needed. The Sr. CRA will work closely with the Clinical Project Managers to ensure the study is executed to meet project deliverables.

Here’s What You’ll Do:

  • Assist Clinical Project Managers in project coordination, planning and logistics, including overview of budget and timelines
  • Present information at investigator meetings as needed
  • Develop clinical monitoring plans and assist in development of associated study documents (Safety Monitoring Plans, Data Management Plans, and Informed Consents)
  • Conduct weekly maintenance and management of study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations
  • Verify that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study
  • Verify that the investigator and research staff follow the approved protocol and all GCP procedures
  • Ensure adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF
  • Communicate deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensure corrective action is implemented
  • Review queries and assist in the resolution of DCFs
  • Participate in project team meetings

Here’s What You’ll Bring to the Table:

  • Bachelor’s degree in a science or related technical field including 4 plus years as an on-site CRA (including pre-study, initiation, interim monitoring and closeout visits)Experience with medical device and/or complex clinical trials desired but not required
  • Prior experience with cardiovascular clinical trials
  • Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials
  • Recognize problems, trends and react to resolve issue quickly and to bring effect resolution
  • Strong attention to detail and an ability to prioritize and juggle multiple/competing issues
  • Ability to create and manage key internal and external partnerships
  • Excellent written and verbal communication skills
  • Ability to travel 50%

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-Remote #LI-DW1

31/05/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Danielle Wilson

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