Clinical Research Associate – FSP

🕒 January 21

🇸🇪 Sweden – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 55%

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.

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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

• 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 SDR, SDV, and CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters according to timelines and approved business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording • Participate in the investigator payment process and findings resolution • Participate in investigator meetings and identify potential investigators with the client company • Initiate clinical trial sites according to procedures, protocol, regulatory, and ICH-GCP obligations • Perform trial close-out and retrieval of trial materials • Ensure essential documents are complete and in place • Conduct on-site file reviews according to project specifications • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • Assist with project publications/tools and contribute ideas to the project team • Contribute to process improvement initiatives and other project work

🎯 Requirements

• University degree in a science related field • Understanding of ICH-GCP, EU and FDA requirements • Fluency in English • Valid driver's license • Proven clinical monitoring skills • Experience from working on Cell & Gene Therapy studies • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated ability to maintain working knowledge of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Good oral and written communication skills, with ability to communicate effectively with medical personnel • Customer focus, good listening skills, attention to detail, and ability to perceive customers’ underlying issues • Good organizational and time management skills • Effective interpersonal skills • Ability to remain flexible and adaptable • Ability to work in a team or independently • Good computer skills, including solid knowledge of Microsoft Office and ability to learn appropriate software • CRA experience from all study phases from start to close-out

🏖️ Benefits

• Competitive salary • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and have fun together • Health and well-being benefits package