Senior CRA – Oncology Experience

🕒 5 days ago

🏄 California – Remote

🏄 California – Remote

💵 $72k - $145k / 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

• Perform and coordinate clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Perform root-cause analysis, identify site-process failures, and implement corrective/preventive actions • Ensure data accuracy through source document review, source data verification, 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 approved monitoring plans • Participate in investigator payment processes • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and CTMS reports • Participate in investigator meetings and identify qualified investigators/sites • Initiate clinical trial sites and make compliance recommendations • Conduct trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, the client company, and the PPD project team • Respond to company, client, and regulatory audits/inspections • Complete expense reports and timesheets • 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 • 2+ years as a clinical research monitor • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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 with medical personnel • Customer focus, listening skills, attention to detail, and ability to perceive underlying issues • Effective interpersonal, organizational, and time management skills • Flexibility and adaptability • Ability to work independently or in a team • Proficient knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures • Ability to travel frequently, generally 60–80%, including overnight stays • Ability to work in office, laboratory, clinical, and/or home-office environments and comply with required personal protective equipment

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • National medical and dental plans • National vision plan • 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 • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with discounted company stock purchases

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