Senior Clinical Research Associate – FSP

🔥 0 minutes ago

⚓ Rhode Island – Remote

⚓ Rhode Island – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 all aspects of clinical monitoring and site management • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required documentation and sponsor procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop relationships with investigational sites • 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 SDR, SDV and CRF review during on-site and remote monitoring • Assess investigational product through inventory and records review • Document observations in reports and letters • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payments and investigator meetings • Track trial status and provide progress updates to the Clinical Team Manager • Update study systems, including CTMS, and perform quality-control checks of CTMS reports • Identify potential investigators and support selection of qualified investigative sites • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications and tools and perform additional study tasks assigned by the CTM • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • 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 • Valid driver's license where applicable • 3+ years as a clinical research monitor, or comparable experience • Combination of appropriate education, training and/or directly related experience may be considered equivalent • 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, including communication with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal skills • Strong attention to detail • Ability to comply with specific sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information • Frequent travel availability, generally 60–80% or more

🏖️ Benefits

• Comprehensive health and wellbeing benefits • Wellness programs • Employee Assistance Program providing confidential support • Flexible arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company-paid parental leave • Paid volunteer time • Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops and mentorship programs • Employee benefits and support as part of an EEO/Affirmative Action employer