Clinical Research Associate

Job Title: Clinical Research Associate (CRA)

Location: Remote with travel across assigned clinical study sites in the United States

Employment Type: Contract (W2 Only)

Duration: 1+ year

Salary/Rate

$40–$42 per hour (or equivalent contract rate), depending on experience, qualifications, therapeutic area exposure, and geographic considerations. This range is provided in good faith as a reasonable estimate consistent with applicable U.S. pay transparency expectations for contract clinical research roles and may vary based on client requirements and candidate background.

Benefits

Contract role – no employer-provided benefits. Any benefits, if applicable, will be provided by the client or sponsoring organization as defined in the assignment agreement.

Job Summary

The Clinical Research Associate (CRA) will support ongoing clinical trials as well as new studies scheduled to begin in the upcoming year. This role is responsible for ensuring high-quality site management, maintaining regulatory compliance, and supporting consistent execution of clinical trial activities. The CRA will act as a key liaison between the sponsor/CRO and assigned study sites, ensuring adherence to study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements while fostering strong site relationships.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in alignment with study protocols, SOPs, and regulatory requirements
• Perform both on-site and remote monitoring activities, including source data verification (SDV) and source data review (SDR)
• Ensure compliance with ICH-GCP guidelines, FDA regulations, and applicable study-specific requirements
• Maintain ongoing oversight of site performance, enrollment, and data quality
• Identify, document, and follow up on protocol deviations, data queries, and corrective actions
• Ensure timely and accurate reporting of adverse events, including serious adverse events (SAEs)
• Support maintenance and review of essential regulatory documents within the TMF/eTMF
• Collaborate with investigators, study coordinators, and internal clinical teams to support study execution
• Ensure accurate and timely documentation of monitoring visits in CTMS and other clinical systems
• Support inspection readiness and participate in audit preparation and response activities
• Escalate site issues, risks, or compliance concerns to clinical leadership as required

Required Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline
• Minimum of 1+ year of experience as a Clinical Research Associate or clinical site monitor
• Strong knowledge of ICH-GCP guidelines and clinical trial regulatory requirements
• Experience with site monitoring activities, including SDV, SDR, and site management
• Familiarity with clinical trial systems such as CTMS, EDC, and eTMF
• Strong organizational skills and attention to detail
• Effective communication and relationship management skills

Work Requirements

• Ability to travel frequently to clinical sites as required by study needs
• Must be able to work independently in a remote environment while managing multiple sites
• Compliance with applicable U.S. federal, state, and local regulations governing remote and contract clinical research work
• Ability to meet sponsor/CRO onboarding, training, and documentation requirements prior to study assignment

Equal Opportunity Employer

The client is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, protected veteran status, or any other status protected under applicable federal, state, or local law.

Application

Interested candidates should submit an updated resume highlighting relevant clinical research monitoring experience and availability for travel. Shortlisted candidates may be contacted for additional screening and client submission requirements.