Sr Cra I Or Cra 2 - Oncology - Fsp West Region (Northern Ca, Nv, Az, Id, Nm, Or, Wa, Co)

3+ years

$120,000 – $133,000

Remote

10 Oct. 4, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

🧪 Senior Clinical Research Associate I (CRA II) - Oncology (FSP West Region)

Available in: Northern CA, NV, AZ, ID, NM, OR, WA, CO
Category: Clinical
Job ID: 254563
Company: Fortrea

🎯 Job Overview

The Senior CRA I (CRA II) plays a critical role in site monitoring and site management for Oncology clinical studies, ensuring compliance with Fortrea/Sponsor SOPs, ICH-GCP, and regulatory guidelines. This position involves study oversight, leadership responsibilities, and coordination of local project activities.

This role is open to experienced Oncology CRAs residing in the Western U.S. region (Northern CA, NV, AZ, ID, NM, OR, WA, CO).

🧠 Key Responsibilities

🔹 Site Monitoring & Management

Conduct pre-study, initiation, routine monitoring, and close-out visits.
Ensure protocol compliance, informed consent procedures, and regulatory adherence at all sites.
Perform detailed source data verification to confirm data accuracy and integrity.
Identify, track, and resolve missing or implausible data.
Maintain audit readiness and ensure regulatory documentation completeness.

🔹 Study Coordination & Oversight

Implement project plans and oversee assigned clinical study deliverables.
Serve as Lead CRA or Local Project Coordinator, managing site communication and study progress.
Coordinate registry management and feasibility studies as per project plans.
Liaise with vendors, investigators, and cross-functional teams.
Assist in protocol, CRF, and clinical report development as assigned.

🔹 Data & Safety Management

Oversee Serious Adverse Event (SAE) reporting, narrative development, and follow-up.
Review CRFs, generate and resolve queries, ensuring compliance with data review guidelines.
Perform QC visits, track findings, and ensure timely corrective actions.

🔹 Stakeholder & Investigator Engagement

Conduct investigator meetings and training sessions.
Recruit potential investigators, prepare ethics committee submissions, and handle regulatory notifications.
Negotiate study budgets and coordinate with Legal for agreements.

🔹 Leadership & Mentorship

Mentor and train junior CRAs through co-monitoring and knowledge sharing.
Manage small-scale projects under the supervision of a Project Manager/Director.
Contribute to continuous improvement and process optimization across study operations.

🔹 Reporting & Documentation

Prepare accurate and timely trip reports and maintain study documentation.
Track project progress, evaluate milestones, and recommend corrective actions.

🎓 Qualifications

📘 Education (Minimum Required)

Bachelor’s degree (Life Sciences preferred) OR
Certification in a related allied health profession (e.g., Nursing, Medical Technology, Laboratory Science).

🔹 Fortrea may consider 3+ years of relevant clinical research experience in lieu of formal education.

💬 Language Skills

Fluent in English (written and verbal).
Proficiency in local office language, if applicable.

💼 Experience (Minimum Required)

Minimum 3 years of clinical monitoring experience in pharmaceutical or CRO industries.
Strong knowledge of:
- Regulatory requirements (FDA, ICH-GCP, local country regulations)
- Drug development lifecycle
Proven expertise in:
- Site monitoring and management
- Registry administration
- SAE reporting and narrative writing
Ability to:
- Work independently with minimal supervision
- Manage multiple priorities and complex timelines
- Function effectively within a matrix team structure

💡 Technical Skills

Proficiency in clinical trial management systems (CTMS) and MS Office Suite.
Strong planning, organizational, and analytical skills.
Valid Driver’s License (required for travel).

🌟 Preferred Qualifications

1+ year additional experience in related fields (e.g., Clinical Data Management, Medical Writing, Pharmacovigilance, Regulatory Affairs).
Prior Local Project Coordination or Project Management experience.

🧭 Key Competencies

Advanced communication and presentation skills
Strong leadership and mentorship abilities
Excellent problem-solving and decision-making skills
High attention to detail, compliance, and audit readiness

✈️ Travel & Work Environment

Travel: 60–80% (including overnight stays)
Environment: Field-based role with frequent site visits and remote documentation

💰 Compensation

Target Pay Range: $120,000 – $133,000 (based on title, experience, and location)

⚖️ Equal Employment Opportunity (EEO)

Fortrea is an Equal Opportunity Employer committed to workplace diversity and inclusion.
Reasonable accommodations will be provided for qualified individuals with disabilities during recruitment and employment.
🔗 Learn more: EEO & Accommodations Information

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Sr Cra I Or Cra 2 - Oncology - Fsp West Region (Northern Ca, Nv, Az, Id, Nm, Or, Wa, Co)

Job Description

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