Clinical Research Associate

Lycia Therapeutics

. Assist with investigator recruitment, site selection, study startup, and close-out tasks .

Posted 11/2/2026full-timeRemote • California • United StatesJuniorMid-Level💰 $125,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research operations, including investigator recruitment, regulatory compliance, and data management. Proficient in utilizing Electronic Data Capture systems and Clinical Trial Management Systems to ensure trial integrity and adherence to ICH-GCP guidelines.

Highest-signal resume keywords

Clinical Research ExperienceElectronic Data Capture (EDC) SystemsClinical Trial Management Systems (CTMS)ICH-GCP GuidelinesRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ReviewRegulatory Document TrackingTrial Master File MaintenanceSite MonitoringProtocol Deviation TrackingAdverse Event DocumentationInvestigational Product AccountabilityMonitoring Visit Report WritingCorrective Action ImplementationSite Performance Indicator Tracking

Soft Skills

Attention to DetailProblem-SolvingEffective CommunicationOrganizationTime Management

Tools & Technologies

Electronic Data Capture (EDC)Clinical Trial Management Systems (CTMS)Remote Monitoring Tools

Industry Keywords

GCPICH GuidelinesFDA RegulationsClinical TrialsSite SelectionInvestigator RecruitmentEthics/IRB Processes

About the role

Key responsibilities & impact

Assist with investigator recruitment, site selection, study startup, and close-out tasks
Provide ongoing operational support to investigative sites via phone and email
Collect, review, and track essential regulatory documents and Investigator Site Files
Maintain the electronic Trial Master File (eTMF)
Review data and findings in Electronic Data Capture systems
Write, track, and follow up on clinical data queries with site personnel
Support traveling CRAs through remote monitoring activities
Track site key performance indicators and update Clinical Trial Management Systems
Ensure trial conduct aligns with GCP, ICH guidelines, FDA/local regulations, and study-specific SOPs
Escalate site non-compliance and protocol deviations to Clinical Operations Management
Conduct qualification, site initiation, interim monitoring, and close-out visits in person or via remote monitoring tools
Review source documents, medical records, and Case Report Forms to verify data accuracy, completeness, and integrity
Identify, document, and track protocol deviations, adverse events, and data queries
Work with site investigators to implement corrective and preventive actions
Check investigational product accountability, storage, dispensing, and return
Maintain comprehensive Trial Master File documents
Write detailed monitoring visit reports within required timelines
Train investigators and clinical research coordinators on study protocols, EDC systems, and regulatory requirements

Requirements

What you’ll need

Bachelor’s or advanced degree in a life science, nursing, pharmacy, or health-related field
2+ years of clinical research experience, such as Clinical Research Coordinator, clinical data assistant, or junior CRA experience
Deep understanding of ICH-GCP guidelines, FDA regulations, EU, and local ethics/IRB processes
Proficiency with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and remote data review tools
Strong attention to detail and problem-solving skills
Effective verbal and written communication
High level of organization and time management
Ability and willingness to travel to assigned clinical trial sites or for co-monitoring, up to 30% travel

Benefits

Comp & perks

Annual bonus
Equity
Generous benefits package