Job Title: Clinical Research Associate II (CRA II) – Phase I | Dallas, Texas
Location: Dallas, Texas, United States (Must reside in the Dallas area)
Job Category: Clinical Research / Clinical Operations
Employment Type: Full-Time
Experience Required: Minimum 2+ years of clinical monitoring experience
Compensation: Target Pay Range: $100,000 – $113,000 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, biotechnology, and medical device companies to accelerate drug and device development through scientific rigor and operational excellence.
The Clinical Pharmacology Team is currently hiring an experienced Clinical Research Associate II (CRA II) with Phase I experience to support early-phase clinical trials in Dallas, Texas.
Position Overview
The Clinical Research Associate II (CRA II) will independently manage and monitor Phase I clinical trial sites, ensuring compliance with protocol, regulatory requirements, ICH-GCP guidelines, and sponsor expectations. This role requires strong site management expertise, data integrity oversight, and the ability to respond appropriately to clinical research-related emergencies.
The ideal candidate is detail-oriented, adaptable in fast-paced research environments, and experienced in early-phase clinical monitoring.
Key Responsibilities
Perform all aspects of clinical site monitoring, including pre-study visits, site initiation visits (SIV), routine monitoring visits (RMV), and close-out visits (COV)
Oversee study site management in alignment with project plans and timelines
Ensure site staff are appropriately trained and equipped to conduct study protocols
Verify informed consent processes and ensure subject safety in accordance with regulatory standards
Review source documentation to ensure accuracy and completeness of Case Report Forms (CRFs) and other data collection tools
Identify, generate, and resolve data queries within sponsor or internal data management systems
Monitor for missing, inconsistent, or implausible data and ensure timely resolution
Manage Serious Adverse Event (SAE) reporting, including narrative preparation and follow-up activities
Conduct registry management activities and feasibility assessments as required
Liaise with vendors and cross-functional stakeholders
Assist with co-monitoring and training of new CRAs
Serve as Local Project Coordinator for designated clinical projects, acting as a local client contact when assigned
Maintain study files and documentation in accordance with regulatory and sponsor requirements
Required Qualifications
University or college degree in life sciences, healthcare, or related field; or certification in an allied health profession (e.g., nursing licensure) from an accredited institution
Minimum 2+ years of independent clinical monitoring experience
Experience monitoring Phase I clinical trials preferred
Comfortable conducting 10–12 days on-site (DOS) per month
Must reside in or near Dallas, Texas
Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes
Preferred Skills
Experience in early-phase or clinical pharmacology studies
Strong organizational and time management skills
Ability to manage multiple priorities in a compliance-driven environment
Proficiency in electronic data capture (EDC) systems and remote monitoring tools
Excellent communication and stakeholder management skills
Work Environment Expectations
Fast-paced, compliance-focused clinical research setting
Strict adherence to study protocols and regulatory requirements
Frequently shifting priorities requiring adaptability
Technology-driven environment utilizing electronic data systems
High collaboration across cross-functional clinical teams
Compensation and Benefits
Employees working 20 or more hours per week are eligible for 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 clinical research through its FOUR values: Forward Together, Own It, Uphold Integrity, and Respect People. As a CRA II within the Clinical Pharmacology Team, you will play a critical role in Phase I drug development—ensuring participant safety, data integrity, and regulatory compliance at the earliest and most foundational stage of clinical research.
This opportunity offers career progression within global clinical operations while contributing to the development of innovative therapies that impact patients worldwide.
Apply now through ThePharmaDaily.com to advance your clinical research career in Phase I studies.
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