Senior Clinical Research Associate, Level I

🔥 1 minute ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage trial documentation, procedures and sponsor-specific guidelines • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs • Ensure audit readiness and maintain collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Document observations, escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical trial systems and perform required CTMS quality checks • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and ensure protocol, regulatory and ICH-GCP compliance • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools and other study tasks • Facilitate communication between sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to project work and process improvement initiatives

🎯 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 of experience as a clinical research monitor • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills • Ability to communicate effectively with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Solid experience in neurology clinical trials • Experience in rare diseases is recommended

🏖️ Benefits

• Fully remote work arrangement • Full-time employment

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