Thermo Fisher Scientific
Biotechnology • Pharmaceuticals • Science
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.
Senior Clinical Research Associate
Job not on LinkedIn
November 21
🗣️🇷🇴 Romanian Required
Thermo Fisher Scientific
Biotechnology • Pharmaceuticals • Science
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.
đź“‹ Description
• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Assess investigational product through physical inventory and records review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Bring ups observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. • Investigates and follow-up on findings as applicable. • Participates in investigator meetings as necessary. • May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. • Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the team as required. • Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
🎯 Requirements
• Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • Valid driver's license. • Good medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents • Good verbal and written communication skills in Romanian and English • Ability to manage Risk Based Monitoring concepts and processes • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
🏖️ Benefits
• health insurance • paid time off • professional development
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