Clinical Research Associate, Various Levels

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🕒 June 26

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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

• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. • Manage procedures and guidelines from different sponsors and/or monitoring environments. • Ensure 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. • Ensure audit readiness and develop collaborative relationships with investigational sites. • Monitor investigator sites with a risk-based monitoring approach. • Apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions. • Ensures data accuracy through SDR, SDV and CRF review. • Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. • 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. • Conduct monitoring tasks in accordance with the approved monitoring plan. • Participate in investigator meetings and help to identify potential investigators in collaboration with the client company. • Initiate clinical trial sites according to the relevant procedures. • Perform trial close out and retrieval of trial materials. • Ensure that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Provide trial status tracking and progress update reports to the team as required. • Facilitate effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. • Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

🎯 Requirements

• At least 2 years experience • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. • Valid driver's license where applicable. • Basic 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 oral and written communication skills, with the ability to communicate effectively with medical personnel • Good interpersonal skills • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Ability to remain flexible and adaptable in a wide range of scenarios • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events