Senior Clinical Research Associate II, Phase I

Fortrea

. Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards .

Posted 9/22/2026full-timeDurham • North Carolina • United StatesSenior💰 $100,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Monitoring, including conducting pre-study visits, managing study sites, and ensuring compliance with regulatory requirements. Proficient in data integrity verification and Serious Adverse Event reporting within clinical trial environments.

Highest-signal resume keywords

Clinical Monitoring ExperiencePhase I ExperienceNursing LicensureElectronic Data CollectionSerious Adverse Event Reporting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementData Integrity VerificationCase Report Form ReviewFeasibility AssessmentProtocol ComplianceMonitoring DataQuery GenerationTraining New EmployeesEmergency ResponseStudy Site Close-Out

Soft Skills

TeamworkAdaptabilityPrioritizationCommunicationPeople Skills

Tools & Technologies

FortreaData Management SystemsElectronic Data Collection Software

Certifications & Qualifications

University or College DegreeCertification in Allied Health Profession

Industry Keywords

Clinical TrialsRegulatory ComplianceInformed Consent ProceduresSerious Adverse EventsClinical Research Standards

About the role

Key responsibilities & impact

Provide a high standard of care for participants in clinical trials and respond to emergency situations based on clinical research standards
Conduct routine monitoring and close-out of clinical sites
Maintain study files
Conduct pre-study and initiation visits
Liaise with vendors
Manage study sites according to project plans
Ensure study staff receive proper materials and instructions
Verify informed consent procedures and protocol requirements comply with regulatory requirements
Verify the integrity of data submitted on Case Report Forms and other data collection tools
Monitor data for missing or implausible data
Manage study registries and undertake feasibility work when requested
Complete Serious Adverse Event reporting, narratives, and follow-up
Perform CRF review, query generation, and resolution using Fortrea or client data management systems
Assist with training new employees through co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator
Act as a local client contact as assigned
Perform other duties as assigned by management

Requirements

What you’ll need

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
3+ years of Clinical Monitoring experience
Phase I experience
40-50% overnight travel
Comfortable working in a fast-paced environment where no deviations from the study protocol are allowed
Ability to prioritize and adapt to constantly changing priorities
Teamwork and people skills
Comfort working in a technology-based environment with electronic data collection
Ability to sit for extended periods and operate a vehicle safely
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional crouching, stooping, frequent bending and twisting of upper body and neck
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Light to moderate lifting and carrying up to 15-20 lbs
Regular and consistent attendance
Varied hours may be required