Senior Clinical Research Associate – Oncology

🕒 September 8

🏄 California – Remote

🏄 California – Remote

💵 $72k - $145k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 11%

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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 and on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures, guidelines and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis and 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 clinical trial systems and perform CTMS report quality-control checks • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of 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 between sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and 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, or comparable experience • Valid driver's license where applicable • Equivalency 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 • Demonstrated 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 • Effective interpersonal skills and attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in 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 • Ability to travel frequently, generally 60–80%, including overnight stays • Ability to use required personal protective equipment and work around biological fluids and infectious organisms

🏖️ 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 • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with discounted company stock • Fully remote work arrangement • Home office environment option

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