Experienced Clinical Research Associate – CRA II, SR CRA

🔥 15 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $84k - $120k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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 all aspects of clinical monitoring and site management • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage sponsor procedures and guidelines across different 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 a risk-based monitoring approach • Apply root cause analysis to 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 through physical inventory and records review • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow up on issues • Participate in investigator payment processes and findings resolution • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress reports to the Clinical Team Manager • Update study systems such as Clinical Trial Management Systems • Facilitate communication between investigative 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 and tools • Contribute to project work and process improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or 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 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Equivalency combining appropriate education, training and/or directly related experience may be considered • 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 • Good oral and written communication skills • Organizational and time management skills • Effective interpersonal skills and attention to detail • Flexibility and adaptability • 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 • Good presentation skills • Ability to travel frequently, generally 60–80%, with up to 75% regional travel and possible extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to use required personal protective equipment

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • Choice of 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), offering eligible colleagues the opportunity to purchase company stock at a discount