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

3+ years
$120K–$133K
10 Oct. 6, 2025
Job Description
Job Type: Full Time 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

Job Title:

Sr CRA I / CRA 2 – Oncology (FSP West Region)

Locations:
Northern CA, NV, AZ, ID, NM, OR, WA, CO (9 locations)

Category: Clinical
Job ID: 254563
Travel Requirements: 60–80% overnight
Target Pay Range: $120K–$133K


Job Overview

The Sr CRA I / CRA 2 is responsible for site monitoring and site management for oncology clinical studies according to Fortrea and/or Sponsor SOPs and regulatory guidelines. The role includes implementing project plans, acting as lead monitor or Local Project Coordinator, and assuming line management responsibilities as assigned.


Primary Responsibilities

Site Monitoring & Management:

  • Conduct routine and closeout monitoring of clinical sites.

  • Ensure study staff are trained and have proper materials to safely enroll patients.

  • Verify adherence to informed consent procedures and protocol requirements.

  • Ensure integrity of data on CRFs or other data collection tools.

  • Monitor for missing, incomplete, or implausible data.

  • Ensure audit readiness at the site level.

  • Prepare timely and accurate monitoring trip reports.

  • Manage travel and monitoring tasks efficiently according to SOPs and travel policies.

Project Coordination & Leadership:

  • Serve as lead monitor or Local Project Coordinator as assigned.

  • Manage small projects under the supervision of Project Manager/Director.

  • Review project progress and take appropriate actions to meet objectives.

  • Organize and present at Investigator Meetings.

  • Participate in protocol and CRF development, and clinical trial report writing.

  • Liaise with vendors and internal workgroups for project needs and timelines.

  • Conduct feasibility assessments and Quality Control (QC) visits as required.

  • Assist in recruitment of investigators, EC submissions, regulatory notifications, and documentation translations.

  • Negotiate study budgets and assist legal department with agreements.

  • Track, report, and follow up on SAEs, including narrative generation and resolution.

  • Perform CRF review, query generation, and resolution on Fortrea or client data systems.

  • Assist with training, mentoring, and development of junior staff.

  • Perform other duties as assigned.


Qualifications / Skills

Minimum Required:

  • University or college degree (life sciences preferred) or certification in allied health, nursing, medical, or laboratory technology.

  • Minimum 3 years relevant clinical research experience if degree not held.

  • Knowledge of regulatory requirements and drug development process.

  • Fluency in local office language and English (written and verbal).

  • 3+ years of clinical monitoring experience.

  • SAE reporting and follow-up knowledge.

  • Advanced site monitoring, site management, and registry administration skills.

  • Ability to work independently and in a matrix project team.

  • Strong planning, organization, computer, and communication skills.

  • Ability to train and supervise junior staff.

  • Valid Driver’s License.

Preferred Qualifications:

  • Additional 1+ year 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

  • Frequent overnight travel (60–80%).