Clinical Research Associate – Level I/II, FSP, Multi Therapeutics

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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

• Perform and coordinate clinical monitoring and site management activities for one specific sponsor • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation and ensure audit readiness • 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 through inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Participate in investigator meetings • Engage daily with sponsor staff and complementary workers • Qualify and initiate clinical trial sites in collaboration with the client company • Perform trial close-out and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • 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 and timesheets • Assist with project publications and tools and contribute ideas • 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 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency may consist of a combination of appropriate education, training and/or directly related experience • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills, including communication with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or in a team • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to travel frequently, generally 60–80%, including possible overnight stays