Senior Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Illinois + 4 moreAll locations: Illinois, Michigan, Minnesota, Missouri, Texas

Posted

3 days ago

Salary

Not specified

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

• The Senior Clinical Research Associate (Senior CRA) plays a critical role in data integrity, patient safety, and overall quality of clinical trials conducted at investigative sites. • The Senior CRA independently monitors trials either onsite or remotely, ensuring compliance with protocols, ICH-GCP guidelines, ICON and/or customer SOPs, and applicable regulatory requirements. • The Senior CRA supports complex studies, contributes to operational excellence, and serves as a mentor to junior staff, while maintaining site readiness for audits and inspections.

Job Requirements

  • A bachelor’s degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
  • 3 years of monitoring required (medical device, pharma, CRO industry).
  • The ideal candidate will have medical device monitoring experience- however, pharma monitoring experience will be considered.
  • Neuro or Neurovascular monitoring experience a plus.
  • In-depth knowledge of FDA regulations and ICH/GCP guidelines.
  • Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
  • Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
  • Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
  • Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
  • Ability to work independently and manage multiple priorities in a dynamic environment.
  • A well-executed plan for communication with the study teams and sites.
  • Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their reports.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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