Senior Clinical Research Associate

September 20

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• Monitors investigator sites with a risk-based approach • Conducts remote or on-site visits to assess protocol and regulatory compliance • Ensures audit readiness • Develops collaborative relationships with investigational sites • Reviews data accuracy through SDR, SDV and CRF review • Participates in the investigator payment process • Ensures trial close out and retrieval of trial materials • Conducts on-site file reviews as per project specifications • Facilitates effective communication between investigative sites, client company and PPD project team • Maintains and completes administrative tasks such as expense reports and timesheets

Requirements

• Bachelor's degree in a life sciences related field • Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) • Valid driver's license • Full Right to work in the UK • Fluency in English language • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills • Ability to handle Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Ability to maintain customer focus • Effective social skills • Strong attention to detail • Effective organizational and time management skills • Ability to remain flexible and adaptable • Ability to work in a team or independently as required • Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software • Good presentation skills