Senior CRA, Level I

🔥 3 hours ago

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 26 days.
• No salary listed.

Apply Now

Find Similar Remote Jobs

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 audit readiness • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis and corrective/preventive actions to address site issues • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform report quality checks • Participate in investigator meetings and identify qualified investigators • Initiate clinical trial sites and ensure protocol, regulatory, and ICH-GCP compliance • Ensure trial closeout and retrieval of trial materials • Maintain complete essential documents and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, the client company, and the project team • Respond to company, client, regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to 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 • Previous experience comparable to 3+ years as a clinical research monitor • Valid driver's license where applicable • Experience required in Oncology and Cell Therapy • 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 maintain customer focus and attention to detail • Effective interpersonal, organizational, and time management skills • Flexibility and adaptability • Ability to work independently or 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 specific sponsor/client/site requirements • Ability to travel frequently and drive to site locations

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume