Clinical Research Associate - Oncology

2-5 years

Not Disclosed

United States

10 April 18, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Research Associate - Oncology - South (Remote)

Location:

Remote (South United States)

Job ID:

2025-118410

Department:

Clinical Monitoring – ICON Strategic Solutions

Job Type:

Full-Time, Remote

Application Contact:

Name: Monica Hawkins
Options: View other roles or send a message via the application platform

Job Description:

As a Clinical Research Associate (CRA), you will be part of a global clinical research team, implementing and monitoring clinical trials in Oncology. This position involves managing clinical trial operations, ensuring compliance with local regulations and ICH-GCP guidelines, and supporting trial sites to meet all obligations and deadlines. You will work remotely to monitor sites and trials, performing essential tasks such as data verification, serious adverse event (SAE) reporting, source document verification, and ensuring the accuracy of study information.

Key Responsibilities:

Implement and monitor clinical trials, ensuring compliance with ICH and GCP guidelines
Assess and qualify investigative sites, initiate trials, and provide site staff with necessary training
Manage site startup, regulatory documents, informed consent, and IRB/IEC submissions
Perform source document verification, query resolution, and trial data accuracy
Ensure investigational product (IP) accountability and SAE reporting
Communicate regularly with investigative sites and provide trial status updates
Escalate site and trial-related issues, ensuring timely resolution
Take a leadership role in complex studies and sites, offering guidance to the clinical operations team

Required Qualifications:

Education: Undergraduate degree or equivalent in clinical, science, or health-related field (licensed healthcare professional or equivalent work experience preferred)
Experience:
- 2-5 years clinical monitoring experience (CRA 2)
- 5+ years clinical monitoring experience (Sr CRA) for senior-level applicants
- Knowledge of ICH and local regulatory authority regulations regarding clinical trials
- Fluency in English (reading, writing, speaking)
Skills:
- Experience with feasibility/site selection and site startup
- Ability to negotiate budgets and interact with functional areas to resolve site issues
- Strong communication and leadership skills for site management
Location: Must be legally authorized to work in the United States
Visa: No sponsorship required now or in the future

What ICON Offers:

Competitive salary and performance rewards
Health insurance, retirement planning, and life assurance
Global Employee Assistance Program for 24/7 support
Paid annual leave, plus additional flexible benefits (e.g., childcare, gym memberships, travel passes)
🔗 Explore ICON Benefits

Diversity & Inclusion Commitment:

ICON is dedicated to fostering an inclusive and accessible environment for all candidates, with equal consideration for employment opportunities.

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Clinical Research Associate - Oncology

Job Description

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