Senior Clinical Research Associate I, Sponsor-Dedicated FSP

Job not on LinkedIn

🔥 2 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

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

Upload Resume

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

• Monitor investigator sites using a risk-based monitoring approach • Apply root-cause analysis, critical thinking, and problem-solving to identify site-process failures 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 in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and findings resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check study systems, including CTMS • Participate in investigator meetings and identify qualified investigators/sites • Initiate clinical trial sites and 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 additional study tasks • Facilitate communication between investigative 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 process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • 2+ years of experience as a clinical research monitor, or comparable experience • Valid driver's license where applicable • Equivalency may be met through a combination of appropriate education, training, and directly related experience • Clinical monitoring skills • 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 with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • 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 • Presentation skills • Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information • 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 • Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Professional development and career opportunities • Reasonable accommodation for individuals with disabilities • Equal employment opportunity