CRA, Clinician to CRA Program

🔥 1 hour ago

🌵 Arizona, California, +3 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🤠 Texas – Remote ⛷️ Utah – Remote

💵 $80k - $133k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 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

• Transition clinician expertise into a Clinical Research Associate role within Thermo Fisher Scientific’s Clinician to CRA Program • Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through Source Data Review, Source Data Verification, and Case Report Form review • Assess investigational product inventory and records • Document observations in reports and letters using approved business writing standards • 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 • Identify potential investigators and initiate clinical trial sites according to procedures • Perform trial close-out and retrieve trial materials • Ensure essential documents are complete and compliant with ICH GCP and regulations • Conduct on-site file reviews • Provide trial status tracking and progress reports • Maintain accurate and current study systems such as CTMS • Facilitate communication among investigative sites, client companies, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports, timesheets, and other administrative tasks • Assist with project publications/tools and contribute ideas for process improvement • Travel frequently, generally 60–80%, with possible extended overnight stays

🎯 Requirements

• Clinicians such as RNs, APRNs, PA’s, MDs, Research Nurse or Clinical Research Coordinator with clinician certification or equivalent and relevant formal academic/vocational training • Comprehensive experience as a clinician in a healthcare environment comparable to at least 2 years • Expertise in a therapeutic area, including Hematology/Oncology, CAR-T and Cell Therapy, Rare Disease, Endocrinology/Diabetes, Ophthalmology, Neurology, Cardiology, Infectious Disease, Respiratory/Pulmonology, Internal Medicine, ICU, or Critical Care, comparable to at least 2 years • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents • Good oral and written communication skills • Good interpersonal skills • Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues • Organizational and time management skills • Flexibility and adaptability • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Must comply with specific sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information • Frequent driving to site locations and travel generally 60–80%; role states travel requirement greater than 75%

🏖️ 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) with the opportunity to purchase company stock at a discount • Global resources, formal training programs, and focused support for career transition • Flexible, regular promotion cycles • Professional development through exposure to therapeutic areas and innovative clinical trials

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