Clinical Research Associate II – Multiple Therapies

🔥 38 minutes ago

🦌 Connecticut, Maine, +3 more states – Remote

🦌 Connecticut – Remote 🦞 Maine – Remote 🏈 Ohio – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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 • Conduct remote or 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 resolve site process failures • Ensure data accuracy through SDR, SDV, 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 investigator meetings • Identify and initiate qualified clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete according to ICH-GCP and applicable regulations • Conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems such as CTMS • Facilitate communication between 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/tools and 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 • Valid driver's license where applicable • 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 • Oral and written communication skills for communicating with medical personnel • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time management skills • Ability to work in a team or independently • Microsoft Office proficiency and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Frequent travel, generally 60–80%, with travel requirement above 75% stated • Ability to comply with sponsor/client/site requirements, including possible vaccination-status disclosure • Ability to work upright and/or stationary for 6–8 hours per day • Ability to lift and carry up to 15–20 lbs • Regular and consistent attendance

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • National medical and dental plans • National vision plan, including health incentive programs • Employee assistance and family support programs • Commuter benefits • 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 • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with discounted company stock purchase opportunity

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