Monitoring Excellence Academy (OMEA) – CRA I (Oncology / CAR-T / Ophthalmology)
Company: Fortrea
Position: Clinical Research Associate I (CRA I) – Monitoring Excellence Academy (OMEA)
Work Model: Remote (United States & Canada)
Employment Type: Full-Time
Job Requisition ID: 262591
Target Salary Range: USD $80,000 – $90,000 per year
Travel Requirement: 60–70% Overnight Travel
Job Overview
Fortrea's Monitoring Excellence Academy (OMEA) is designed to develop experienced Clinical Research Coordinators (CRCs) and Research Nurses into Clinical Research Associates (CRAs). This opportunity is ideal for candidates with strong experience in:
Oncology Clinical Trials
CAR-T Cell Therapy Studies
Ophthalmology Studies
The role focuses on site monitoring, patient safety oversight, protocol compliance, data quality, and site management while supporting clinical trials across multiple research sites.
Ideal Candidate Profile
Candidates should have:
2+ years of current experience as a:
Clinical Research Coordinator (CRC)
Research Nurse
Therapeutic experience in:
Oncology (preferred)
CAR-T Therapy
Ophthalmology
Strong understanding of clinical trial operations.
Willingness to travel extensively (60–70%).
Key Responsibilities
Site Monitoring
Conduct:
Pre-Study Visits (PSV)
Site Initiation Visits (SIV)
Routine Monitoring Visits (RMV)
Close-Out Visits (COV)
Maintain study files and monitoring documentation.
Liaise with investigators, site staff, vendors, and project teams.
Ensure study sites remain compliant throughout the trial lifecycle.
Site Management
Manage assigned sites according to project plans.
Support site performance and issue resolution.
Track study progress and monitoring activities.
Assist with feasibility assessments when required.
Patient Safety & Protocol Compliance
Verify:
Informed Consent Procedures
Eligibility Criteria
Protocol Compliance
Regulatory Compliance
Ensure protection of study participants.
Identify protocol deviations and ensure corrective actions are implemented.
Data Quality & Review
Review:
Case Report Forms (CRFs)
Source Documents
Electronic Study Data
Monitor for:
Missing Data
Inconsistent Data
Implausible Entries
Generate and resolve data queries according to study requirements.
Serious Adverse Event (SAE) Management
Support:
SAE Reporting
Narrative Preparation
Follow-up Activities
Safety Documentation
Ensure safety events are documented accurately and reported within required timelines.
Registry & Clinical Project Support
Support registry management activities.
Assist with project coordination activities.
May serve as:
Local Project Coordinator
Local Client Contact (under supervision)
Training & Mentorship
Assist with onboarding and training new team members.
Participate in co-monitoring activities.
Share best practices and study knowledge.
Required Qualifications
Education
One of the following:
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Medical Sciences
Allied Health Sciences
OR
Professional certification in an allied health discipline such as:
Registered Nurse (RN)
Research Nurse
Other accredited healthcare professions
Experience
Mandatory
Minimum 2 years of experience as:
Clinical Research Coordinator (CRC)
Research Nurse
Preferred
Oncology Clinical Trials
CAR-T Studies
Ophthalmology Research
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