Senior Clinical Research Associate – UK

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🕒 January 6

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

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.

📋 Description

• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • 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. • Assesses investigational product through physical inventory and records review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Brings up 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 follows-up on findings as applicable. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). • Performs QC check of reports generated from CTMS system where required. • Participates in investigator meetings as necessary. • Identifies 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. • Ensures 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.

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • 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, including but not limited to: critical attitude, in-depth investigation for appropriate root cause analysis and decision-making. • Ability to handle Risk Based Monitoring concepts and processes. • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel. • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues. • Effective social skills. • Strong attention to detail. • Effective organizational and time management skills. • Ability to remain flexible and adaptable in a wide range of scenarios. • 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.

🏖️ Benefits

• Competitive sign-on bonus considered for qualified candidates