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Ophthalmology & Biopharma - Cra Ii

1-3 years
$105,000 – $117,000
10 Nov. 11, 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

Ophthalmology & Biopharma – Clinical Research Associate II (CRA II)

Category: Clinical
Job ID: 255475
Locations: Remote US (available in 15 locations)
Travel: 60–70% (8–10 days onsite per month)


Role Overview

Fortrea is seeking experienced Ophthalmology & Biopharma CRA II professionals to support and lead clinical activities within its Full-Service Outsourcing (FSO) team. The role is remote with extensive travel and requires strong monitoring expertise, clinical judgment, and ability to manage complex ophthalmology/biopharma studies.


Key Responsibilities

1. Site Monitoring & Trial Oversight

  • Perform all required onsite/remote monitoring activities including:

    • Pre-study visits

    • Site initiation visits

    • Routine monitoring

    • Close-out visits

  • Maintain complete and compliant study files according to project plans.

  • Liaise with vendors and external stakeholders.

  • Conduct general onsite monitoring to ensure regulatory and protocol compliance.

2. Patient Safety & Protocol Adherence

  • Ensure site staff are fully trained and equipped before patient enrollment.

  • Confirm proper informed consent procedures.

  • Verify strict adherence to ICH-GCP, protocol requirements, and regulatory guidelines.

  • Protect patient rights, safety, and welfare throughout the study.

3. Data Quality & Documentation

  • Validate data accuracy through source document verification.

  • Identify and resolve missing, inconsistent, or implausible entries.

  • Independently review Case Report Forms (CRFs) and manage query generation/resolution.

  • Complete and manage Serious Adverse Event (SAE) reporting, narratives, and follow-up.

  • Support registry management and feasibility assessments as required.

4. Project Coordination & Team Support

  • Assist in onboarding and training new CRAs, including co-monitoring activities.

  • Act as a Local Project Coordinator, with supervision when necessary.

  • Serve as a local client contact as assigned.

  • Perform additional tasks as directed by management.


Requirements

Education

  • Bachelor’s degree or certification in allied health (e.g., nursing licensure).

Experience

  • 1–3 years of Clinical Monitoring experience.

  • Ophthalmology therapeutic area experience desired.

  • Open to major hub locations on the East & West Coast.

Work Style Expectation

Must thrive in an environment that is:

  • Fast-paced, with zero tolerance for protocol deviations.

  • Time-sensitive, where even short delays impact quality.

  • Dynamic, requiring ongoing prioritization and adaptability.

  • Collaborative, demanding strong teamwork and communication.

  • Technology-driven, with fully electronic data capture systems.


Compensation & Benefits

Eligible employees (20+ hours/week) receive:

  • Medical, Dental, Vision, Life Insurance

  • Short-Term & Long-Term Disability

  • 401(k)

  • Paid Time Off (PTO) – Flex Plan

  • Employee Recognition Awards

  • Multiple Employee Resource Groups (ERGs)

  • Target Pay Range: $105,000 – $117,000


Work Environment

  • Remote home-office setup.

  • Regular travel to clinical sites (domestic; occasional international).

  • Frequent use of electronic systems and office equipment.


Physical Requirements

  • Ability to sit for long periods and safely operate a vehicle.

  • Frequent repetitive hand movements (typing, documentation).

  • Occasional crouching, stooping; frequent bending/twisting.

  • Ability to lift/carry 15–20 lbs (e.g., luggage, laptop).

  • Consistent attendance required; flexible working hours may apply.