Clinical Research Associate Jobs

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About The Position

The Senior Clinical Research Associate monitors clinical study progress at investigative sites or remotely and ensures trials are conducted, recorded, and reported in accordance with study protocols, standard operating procedures, ICH-GCP, and applicable regulatory requirements. This is a home-based role open to candidates across the Western United States, with travel to research sites approximately 65% of the time. The position focuses on clinical research in dermatology and rheumatology. Indero is a contract research organization specializing in these therapeutic areas and is based in Montreal, with operations across North America and Europe.

Requirements

  • B.Sc. in a field relevant to clinical research, a nursing degree, and/or equivalent experience.
  • 5 to 8 years of experience conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization industry.
  • Good knowledge of ICH-GCP standards and applicable regulatory requirements.
  • Strong verbal and written communication skills in English.
  • Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines.
  • Excellent judgment and problem-solving skills.
  • Ability to travel to research sites approximately 65% of the time.
  • Excellent knowledge of Microsoft Office, including Word, Excel, and PowerPoint.
  • Applicants must be legally authorized to work in the United States.

Nice To Haves

  • Experience in dermatology.

Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits according to monitoring plans, company and sponsor SOPs, ICH-GCP guidelines, and applicable regulations.
  • Participate in investigators’ meetings.
  • Prepare site visit reports and follow-up letters to investigators.
  • Build productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets.
  • Perform source data verification and ensure adequate on-site study drug storage, dispensing and accountability, data collection, and regulatory document collection.

Benefits

  • Vacation and sick days.
  • 401(k).
  • Benefits.
  • Traveling position with a teleworking allowance.
  • Ongoing learning and development.
  • Stimulating work environment and attractive advancement opportunities.

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