Clinical Research Associate

3 weeks ago


Pittsburgh, Pennsylvania, United States Thermo Fisher Scientific Full time

Job Summary:

This Clinical Research Associate position is responsible for conducting clinical monitoring and site management activities for clinical trials. The successful candidate will have a strong understanding of medical/therapeutic area knowledge and medical terminology, as well as excellent communication and problem-solving skills.

Key Responsibilities:

  • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
  • Manage procedures and guidelines from different sponsors and/or monitoring environments.
  • Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs.
  • Monitor investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions.
  • Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Document observations in reports and letters in a timely manner using approved business writing standards.

Requirements:

  • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
  • Fluent in Spanish language, speaking - writing.

What We Offer:

  • A competitive salary range of $83,000 annually - $125,000 annually.
  • A choice of national medical and dental plans, and a national vision plan.
  • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA).
  • Tax-advantaged savings and spending accounts and commuter benefits.
  • Employee assistance program.
  • Paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy.

About Thermo Fisher Scientific:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.



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