Senior Clinical Research Associate

🕒 5 days 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

• Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance • Manage clinical monitoring documentation, procedures, and sponsor guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Build collaborative relationships with investigative sites and client company personnel • Support project managers and clinical team managers on assigned projects • Mentor, train, and contribute to the development of junior clinical team members • Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems such as CTMS and perform required quality-control checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, clients, and the PPD 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 science related field or equivalent and relevant formal academic / vocational qualification • Considerable clinical research monitoring experience comparable to 5+ years • Demonstrated high level of expertise in all aspects of clinical monitoring • Expert clinical monitoring skills • Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents • Excellent critical thinking, root cause analysis and problem-solving skills • Proficient in Risk Based Monitoring concepts and processes • Ability to evaluate medical research data • Proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal skills • Excellent organizational and time management skills • Strong attention to detail • Flexibility and adaptability in a wide range of scenarios • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to travel frequently, generally 60–80%, with possible extended overnight stays • Ability to work in an office, laboratory, clinical, and/or home office environment • Ability to work upright and/or stationary for 6–8 hours per day • Frequent mobility • Ability to lift and carry 15–20 lbs • Ability to use a variety of computer software • Regular and consistent attendance

🏖️ Benefits

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility assistance or accommodation during the job application process, where required

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