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Clinical Research Associate (Level II) - FSP Oncology - California/Nevada
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Clinical Research Associate (Level II) - FSP Oncology - California/Nevada

ThermoFisher

Early applicant

Remote

Employee

Full-Time

Mid Level

Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assesses investigational product through physical inventory and records review. Documents observations in reports...

Skills

Risk-based monitoring

Root cause analysis

Critical thinking

Problem-solving

Data accuracy

SDR

SDV

CRF review

Investigational product assessment

Business writing

Clinical management

Protocol compliance

Regulatory compliance

ICH GCP

Investigator payment process

Project team collaboration

Investigator meetings

Clinical trial initiation

Essential document management

On-site file review

Trial status tracking

Clinical Trial Management System (CTMS)

Communication

Client relationship management

Audit response

Inspection response

Administrative tasks

Expense reporting

Timesheet management

Project publications

Process improvement

Clinical monitoring

Therapeutic area knowledge

Medical terminology

Risk Based Monitoring concepts

Interpersonal skills

Attention to detail

Adaptability

Teamwork

Independent work

Microsoft Office

Presentation skills