Job Description – CRA – Site Manager


TITLE: Clinical Research Associate (CRA) – Site Manager

Company:   Global BioClinical
Location:   Seattle, WA
Type:   Full Time with Travel


The Clinical Research Associate (CRA) – Site Manager will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out.

Responsibilities will Include:

  • Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
  • Carries out clinical site qualification, contract negotiation, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
  • Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
  • Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
  • Conducts clinical site and data monitoring and completes monitoring visit reports
  • Supports study supply, biospecimen delivery, and biospecimen testing logistics
  • Evaluates clinical data and coordinates data query resolutions
  • Supports internal departmental quality compliance
  • Prepares progress reports and performance metrics
  • Required travel to investigative sites up to 10%

Skills and Qualifications:

Clinical Research Competencies:

  • >2 years clinical site management and monitoring experience
  • Understands and can apply knowledge of clinical trial designs to trial execution
  • Advanced knowledge and experience with GCP/ICH and local regulations
  • Experience in web-based data collection applications, knowledge of key areas for compliance

Non-Clinical Experience:

  • Strong communication skills as single point of contact for investigator
  • Excellent organizational skills with high attention to detail is required
  • Strong computer skills (spreadsheets, word processing, etc) is required
  • Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
  • Strong skills in building and maintaining relationships with investigative sites
  • Strong presentation skills to internal professionals and external collaborators

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