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Company

ICON Strategic Solutions · 3 days ago

Senior CRA- CA

United States

Full-time

Remote

Mid, Senior Level

4+ years exp

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Pharmaceutical Manufacturing

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Responsibilities

The Sr. Clinical Research Associate will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

Applies knowledge of ICON’s policies and procedures

Demonstrates excellent written and oral communication

Demonstrates excellent knowledge of ICH/GCP

Displays ability to manage investigative sites to facilitate trial deliverables

Demonstrates ability to escalate issues appropriately

Conducts monitoring to confirm subject safety and data integrity

Describes and demonstrates the principals of IP accountability

Identifies scientific misconduct at the site level

Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms

Mentors CRAs new to the position or company

Serves as an observation visit leader

Conducts monitoring evaluation visits

Assists team lead in the development of trial tools or documents

Assists with CTM tasks

Participates in the development of process changes/improvements

Presents at client meetings/Investigator meetings

Provides training to trial teams

Qualification

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Clinical ResearchICH/GCP KnowledgeMonitoring ExperienceMicrosoft OfficeClinical Trial Management SystemsIVRS/IWRSElectronic Data CaptureEnglish FluencyScientific Misconduct IdentificationProcess ImprovementMentoring

Required

Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required

Read, write and speak fluent English; fluent in host country language required

2 years of experience supporting clinical trials including 1 year of on-site monitoring experience (for CRA2); 4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for CRA3)

Ability to travel for approximately 10 site visits each month

Proven success monitoring fast paced trials with quick turnaround times for database lock

High proficiency with Microsoft Office and company collaboration applications

Advanced skill in utilization of applicable clinical systems

Preferred

Experience in monitoring all trial components (PSSV to COV)

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others