Senior CRA - FSP - Medical Device

🕒 July 24

🦬 Montana – Remote

🦬 Montana – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 44%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures, guidelines, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification, and case report form review • Assess investigational products through physical inventory and records review • Document observations in reports and letters; escalate deficiencies and track issues through resolution • Maintain contact with sites between monitoring visits to confirm protocol adherence, issue resolution, and timely data recording • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical study systems, including clinical trial management systems, and perform required quality checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites in collaboration with the client • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Assist with project publications, tools, team calls, trip report reviews, and newsletters • Facilitate communication among investigative sites, the client, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports, timesheets, and other administrative tasks • Contribute to project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor, or comparable experience • Valid driver's license where applicable • Appropriate education, training, and/or directly related experience may be considered as an equivalency • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application of ICH GCPs, applicable regulations, and procedural documents • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Effective interpersonal, organizational, and time management skills • Flexibility and adaptability • Ability to work independently or as part of a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor, client, and site requirements, including potential disclosure of vaccination status or other personal information • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to use required personal protective equipment and work around biological fluids, infectious organisms, electrical equipment, and fluctuating temperatures

🏖️ Benefits

• Frequent travel generally 60–80%, with travel expenses presumably associated with the role • Opportunity to work as part of a global team • Participation in investigator meetings and project initiatives • Professional exposure to pharmaceutical, biotechnology, and medical device clinical research • Personal protective equipment provided/required, including protective eyewear, garments, and gloves