Senior CRA I – Multiple Therapies

🔥 45 minutes ago

🦌 Connecticut, Maine, +6 more states – Remote

🦌 Connecticut – Remote 🦞 Maine – Remote 🗻 New Hampshire – Remote 🗽 New York – Remote 🏈 Ohio – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote

💵 $105k - $112k / year

⏰ 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

• Act as a representative of one specific client in the FSP model • Perform and coordinate all aspects of clinical monitoring and site management • 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 physical inventory and records review • Document observations in reports and letters using approved business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain regular contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial management systems and perform QC checks of CTMS-generated reports • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout, retrieval of trial materials, and completion of essential documents • Conduct on-site file reviews • Contribute to project publications, tools, process improvements, and other project initiatives • Facilitate communication among investigative sites, the client company, and project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete administrative tasks such as expense reports and timesheets

🎯 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 providing the knowledge, skills, and abilities to perform the job, comparable to 3+ years • Oncology experience preferred • Strong critical thinking and problem-solving skills • Excellent clinical trials monitoring skills, both remote and on-site • Demonstrated understanding of ICH-GCP guidelines, applicable regulations and SOPs • Strong communication and collaboration skills • Advanced written and oral communication skills • Strong organizational skills and attention to detail • Demonstrated use of computer systems including CTMS and other trial management platforms • Ability to travel >75% as required for site monitoring activities

🏖️ Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO) • 10 paid holidays annually • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) • Accident and life insurance • Short- and long-term disability in accordance with company policy • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount • Variable annual bonus eligibility based on company, team, and/or individual performance results • Health incentive programs

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