Senior CRA I/II - FSP

🕒 July 6

🇳🇴 Norway – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 45%

What it means: the chance that no one is really hiring for this job.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.

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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 clinical trial documentation, procedures, and sponsor monitoring requirements • 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 risk-based monitoring, including RCA, SDR, SDV, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters; escalate and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform report quality-control checks • Participate in investigator meetings, site identification, site initiation, and trial closeout • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, the client company, and the project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to process improvement initiatives and other assigned project work

🎯 Requirements

• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • At least 3 years of experience as a CRA • At least 2 years of on-site, hands-on Oncology/Cell therapy experience • 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 • Ability to maintain customer focus and identify underlying issues • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently and in 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 • Willingness and ability to travel frequently, generally 60-80%, including overnight stays • Ability to use required personal protective equipment and work around biological fluids and infectious organisms

🏖️ Benefits

• Frequent travel, generally 60-80% but more for some individuals • Remote work/home office environment • Personal protective equipment provided/required as applicable

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