Job Title: Clinical Research Associate II (CRA II) – Oncology / CAR-T | Remote U.S.
Location: Remote – United States (Available in 15 U.S. Hub Locations)
Job Category: Clinical Research / Clinical Operations
Employment Type: Full-Time (Full Service Outsourcing Model)
Experience Required: 1–3+ years of clinical monitoring experience (Oncology required; CAR-T preferred)
Travel Requirement: 60–70% travel | 8–10 Days On-Site (DOS) per month
Compensation: Target Pay Range: $105,000 – $117,000 annually
Application Status: Open – Applications accepted on an ongoing basis
About the Organization
Join Fortrea, a leading global Contract Research Organization (CRO) delivering end-to-end clinical development and technology solutions across more than 20 therapeutic areas. Operating in approximately 100 countries, Fortrea partners with pharmaceutical and biotechnology innovators to accelerate the development of advanced therapies, including oncology and cell and gene treatments.
Through its Full Service Outsourcing (FSO) model, Fortrea provides embedded clinical expertise and operational excellence across complex therapeutic programs.
Position Overview
Fortrea is seeking experienced Clinical Research Associate II (CRA II) professionals with oncology expertise to support oncology and CAR-T clinical trials across the United States. This role is ideal for CRAs with experience in hematologic malignancies, solid tumors, or advanced cell therapies who are ready to contribute to high-impact oncology programs.
The CRA II will be responsible for comprehensive site monitoring, regulatory compliance, patient safety oversight, and data integrity within oncology trials, including complex CAR-T studies where applicable.
Key Responsibilities
Conduct pre-study, site initiation (SIV), routine monitoring (RMV), and close-out visits (COV)
Ensure study sites operate in compliance with ICH-GCP, FDA regulations, sponsor requirements, and protocol specifications
Verify informed consent procedures and patient protection standards
Perform detailed source document review and ensure accurate Case Report Form (CRF) completion
Identify missing, inconsistent, or implausible data and manage query resolution in electronic data capture (EDC) systems
Oversee Serious Adverse Event (SAE) reporting, including documentation, narrative preparation, and follow-up
Manage registry activities and perform site feasibility assessments as required
Maintain essential regulatory documentation and ensure audit readiness
Liaise with vendors, sponsors, and cross-functional study teams
Support co-monitoring and onboarding of new CRAs
Serve as Local Project Coordinator or primary site contact when assigned
Required Qualifications
University or college degree in life sciences, healthcare, or related discipline; or certification in an allied health profession (e.g., nursing licensure) from an accredited institution
1–3+ years of independent clinical monitoring experience
Oncology clinical trial experience required
CAR-T or cell and gene therapy experience preferred
Strong understanding of ICH-GCP, FDA regulations, and oncology trial complexities
Ability to travel 60–70% with 8–10 DOS per month
Strong organizational, communication, and stakeholder management skills
Preferred Competencies
Experience in hematology/oncology trials or advanced biologics
Knowledge of oncology safety reporting requirements
Experience working within Full Service Outsourcing (FSO) or embedded sponsor models
Proficiency in electronic clinical trial management systems
Work Environment
Remote/home-based position within the United States
Frequent domestic travel to investigative sites; occasional international travel may be required
Office-based work involving electronic systems and regulatory documentation
High-performance, compliance-driven environment
Physical Requirements
Ability to sit for extended periods and operate a vehicle safely
Frequent computer use with repetitive hand and wrist movements
Occasional bending, stooping, and lifting (15–20 lbs, including laptop and travel equipment)
Flexibility to work varied hours based on study demands
Compensation and Benefits
Eligible employees working 20 or more hours per week receive comprehensive benefits, including:
Medical, Dental, and Vision Insurance
Life Insurance and Short-Term/Long-Term Disability coverage
401(k) Retirement Plan
Paid Time Off (PTO) – Flex Plan
Employee Recognition Programs
Employee Resource Groups (ERGs)
Why Join Fortrea
Fortrea is committed to advancing oncology innovation and accelerating access to transformative therapies such as CAR-T and other cell and gene treatments. As a CRA II in Oncology, you will play a critical role in ensuring patient safety, regulatory compliance, and high-quality data across cutting-edge oncology programs.
This opportunity offers therapeutic specialization, career progression, and involvement in complex oncology trials that directly impact patient outcomes.
Apply now through ThePharmaDaily.com to advance your career in oncology clinical research and contribute to the future of cancer treatment.
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