Senior Regional Site Manager - WA in Seattle, WA at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Seattle, WA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/9/2018
  • Job ID:
    865419

Job Description


Description: 

  • The Regional Site Manager is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected.
  • The RSM conducts all monitoring visits in accordance with standards.
  • The Principle exercises responsibility across multiple projects and therapeutic areas.
  • The RSM interfaces with clinical investigators, other site staff and personnel in order to carry out this responsibility.
  • The RSM is completely accountable for site management and data quality for each assigned site. 
  • The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

Responsibilities: 

  • Responsible for all site management activities for Phase 1-IV trials, across multiple therapeutic areas.
  • Including, but not limited to communication, training, recruitment, data entry, TMF maintenance, issue escalation, resolution of action items and protocol adherence. 
  • Conduct the following monitoring visits according to GCP/ICH guidelines, applicable SOPs, Working Documents, Protocol Specific Monitoring Plans, and departmental timelines: 
    • Site Qualification Visits (SQVs) 
    • Site Initiation Visits (SIVs) 
    • Interim Monitoring Visits (IMVs) Remote Monitoring Visits (RMVs) 
    • Close out Visit (COVs) 
  • Manage assigned tasks according to organization timelines. 
  • Manage multiple priorities in various degrees of complexity 
  • Ensure all assigned training is completed as expected 

Minimum Requirements: 

  • BA/BS degree 
  • 5 years of experience as a Clinical Research Associate
  • Experience monitoring medical device, dermatology or ophthalmology studies. 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.