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Ophthalmology - Cra Ii

Fortrea
Fortrea
1-3 years
USD 105,000 – 117,000 per year
United States
10 Feb. 24, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 Clinical Research Associate II (CRA II)

Location: Multiple Major Hub Locations – East Coast & West Coast, United States
Category: Clinical Operations
Job ID: 255475
Employment Type: Full-Time
Travel Requirement: 60–70% (8–10 Days On Site per Month)
Experience Required: 1–3 Years Clinical Monitoring Experience (Ophthalmology Required)
Compensation: Target Pay Range USD 105,000 – 117,000 per year

About the Company

Fortrea is a global contract research organization (CRO) providing full-service clinical development solutions to pharmaceutical, biotechnology, and medical device sponsors. The organization’s Full-Service Outsourcing (FSO) model supports complex therapeutic programs across global clinical trial networks.

Role Overview

Fortrea is seeking experienced Ophthalmology Clinical Research Associates (CRA II) to lead and support ophthalmic clinical trials across multiple U.S. hub locations. This role requires therapeutic expertise in ophthalmology and strong site monitoring capabilities to ensure regulatory compliance, patient safety, and data integrity.

The position involves extensive travel and collaboration with cross-functional teams in a technology-driven clinical environment.

Key Responsibilities

Clinical Site Monitoring & Oversight

  • Conduct pre-study, site initiation, routine monitoring, and close-out visits

  • Manage all aspects of study site operations in alignment with approved project plans

  • Maintain essential documents and regulatory binders per GCP requirements

  • Liaise with vendors and sponsor representatives as required

Participant Safety & Regulatory Compliance

  • Ensure proper informed consent procedures are followed

  • Verify adherence to study protocol and regulatory guidelines

  • Safeguard subject safety throughout study conduct

  • Complete Serious Adverse Event (SAE) reporting, narratives, and follow-ups

Data Quality & Source Verification

  • Perform source document verification (SDV)

  • Review Case Report Forms (CRFs) and electronic data capture (EDC) entries

  • Identify missing or inconsistent data and generate queries

  • Independently manage query resolution in sponsor or CRO systems

Project Coordination & Leadership Support

  • Support registry management and feasibility assessments

  • Assist with onboarding and co-monitoring of new CRAs

  • Serve as Local Project Coordinator when assigned

  • Act as local sponsor contact under supervision

Educational Qualification & Experience Requirements

  • University or college degree, or certification in an allied health profession (e.g., Nursing or equivalent accredited qualification)

  • 1–3 years of clinical monitoring experience

  • Mandatory experience in ophthalmology clinical trials

  • Willingness to travel 60–70% (8–10 DOS per month)

  • Open to major East Coast and West Coast hub locations

Core Competencies

  • Strong understanding of Good Clinical Practice (GCP)

  • Knowledge of ICH Guidelines and regulatory frameworks

  • Expertise in ophthalmology therapeutic area monitoring

  • High attention to detail and documentation accuracy

  • Ability to manage dynamic timelines and fast-paced study environments

  • Strong communication and teamwork skills


Work Environment

  • Office-based administrative work with frequent travel to clinical sites

  • Occasional domestic and international travel

  • Technology-driven data capture and reporting systems

  • Ability to sit for extended periods and travel with light equipment (15–20 lbs)

  • Flexibility to work varied hours as required by study timelines

Compensation & Benefits

Eligible employees working 20+ hours per week may receive:

  • Medical, Dental, Vision, Life Insurance, STD/LTD

  • 401(k) Retirement Plan

  • Paid Time Off (PTO) – Flex Plan

  • Employee Recognition Programs

  • Employee Resource Groups (ERGs)

Application Information

Applications are accepted on an ongoing basis.

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