Senior CRA, FSP

🔥 2 hours ago

🇧🇷 Brazil – 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 required documentation and sponsor/monitoring-environment procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root-cause analysis, and corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product through inventory and records review • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Team Manager • Update clinical study systems, including CTMS, and perform required report quality checks • Participate in investigator meetings and identify qualified investigators and sites • Initiate clinical trial sites and ensure trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools, team calls, and other study tasks • Facilitate communication among investigative sites, client company, and project team • Respond to company, client, and 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 • Minimum of 3 years of completed on-site clinical monitoring experience • Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including in-depth investigation for root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, including communication with medical personnel • Effective interpersonal, organizational, and time management skills • Strong attention to detail • 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, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments and use required personal protective equipment

📊 Check your resume score for this job

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

Upload Resume