Senior Clinical Research Associate – FSP

🔥 6 hours ago

🇨🇴 Colombia – 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 sponsor procedures, guidelines, documentation, and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, including RCA, SDR, SDV, 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 updates to the Clinical Team Manager • Update clinical trial systems and perform required CTMS report quality checks • Participate in investigator meetings and identify qualified investigators and sites • Initiate sites, ensure trial closeout, and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools, team calls, and other CTM-assigned study tasks • Facilitate communication among investigative sites, the client company, and the project team • Respond to company, client, and regulatory audits and inspections • Complete expense reports, timesheets, and other administrative tasks • Contribute to project work and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Minimum of 3 years of completed on-site clinical monitoring experience • Experience in infectious disease (pneumonia) and ophthalmology clinical studies preferred • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated 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 with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Interpersonal, organizational, and time management skills • Ability to work flexibly, adaptably, independently, and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures • Ability to travel frequently, generally 60–80%, including frequent drives and possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments and use required personal protective equipment

🏖️ Benefits

• Fully remote work arrangement • Full-time employment

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