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

3+ years

Not Disclosed

Remote

10 Sept. 25, 2025

Job Description

Job Type: Full Time Hybrid Remote 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

Sr CRA I / CRA II – Oncology – FSP West Region

Locations: Northern CA, NV, AZ, ID, NM, OR, WA, CO (9 locations)
Category: Clinical
Job ID: 254563
Target Pay Range: $120,000 – $133,000

Job Overview

The Senior CRA I (or CRA II) is responsible for site monitoring, site management, and clinical study oversight in Oncology trials. The role ensures compliance with Fortrea and Sponsor SOPs, regulatory guidelines, and project plans. Functions may include acting as Local Project Coordinator or Lead CRA for projects of limited scope.

Key Responsibilities

1. Site Monitoring & Management

Conduct routine and closeout monitoring of clinical sites.
Maintain study files and perform pre-study and initiation visits.
Ensure study staff are prepared to safely enroll patients per protocol.
Verify informed consent and protocol adherence to regulatory requirements.
Monitor CRFs and other data collection tools for accuracy and completeness.
Ensure efficient use of Sponsor and Fortrea resources, including travel management.
Maintain site audit readiness.
Prepare accurate and timely trip reports.

2. Project & Study Oversight

Manage small projects under direction of Project Manager/Director.
Serve as lead monitor for protocols/projects and assist in monitoring plan development.
Review project progress and initiate corrective actions to achieve objectives.
Organize and present at Investigator Meetings.
Participate in protocol and CRF development, clinical trial reports, and QC visits.
Conduct feasibility assessments and investigator recruitment as requested.
Negotiate study budgets with investigators and assist legal department with agreements.

3. Safety & Data Management

Track and follow-up on Serious Adverse Event (SAE) reporting, including narratives and reports.
Perform CRF review, query generation, and resolution per guidelines.
Support training, mentoring, and development of new employees.

4. Coordination & Liaison

Act as Local Project Coordinator or local client contact as assigned.
Coordinate with internal teams, vendors, and regulatory authorities.
Handle registry management per project plans.

5. Other Duties

Perform additional tasks as assigned by management.

Qualifications

Minimum Required:

University/college degree (life sciences preferred) or relevant allied health certification; OR ≥3 years clinical research experience in pharma/CRO.
Knowledge of regulatory requirements and drug development process.
Fluent in English and local office language (written and verbal).
Valid Driver’s License.

Experience (Minimum Required):

≥3 years Clinical Monitoring experience.
Full understanding of SAE reporting and follow-up.
Advanced site monitoring, site management, and registry administration skills.
Ability to work independently and within project teams.
Good planning, organization, and computer skills.
Ability to train and supervise junior staff.
Problem-solving and prioritization skills in a matrix environment.

Preferred Qualifications:

Additional experience in medical, clinical, pharmaceutical, laboratory, research, data analysis, data management, or technical writing.
Local project coordination or project management experience.

Physical Demands & Work Environment

Travel requirement: 60–80% overnight.

EEO & Accommodations

Learn more about Fortrea’s Equal Employment Opportunity and accommodations here.

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

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