Clinical Research Associate/Sr. Clinical Research Associate - Western US - FSP

Parexel • United States-California-Remote, CA

2d

About The Position

The Clinical Research Associate (CRA) is responsible for site management, monitoring, and close-out of assigned clinical trial investigator sites to ensure patient safety and quality study execution in accordance with applicable laws, Good Clinical Practices (GCP), and Sponsor standards. The CRA manages site relationships and assigned operational activities from site activation through database lock, supports effective trial delivery and enrollment, safeguards site quality and compliance, and maintains investigator and site staff engagement. The CRA resolves protocol-related site issues and works closely with the Site Care Partner (SCP) and study team throughout site set-up, trial conduct, and close-out.

The role involves conducting onsite and remote/electronic monitoring, supporting site activation and recruitment, training site personnel, monitoring adverse events and serious adverse events, managing study documentation and reporting, addressing site issues and data queries, overseeing investigational product at sites, and supporting database release. The CRA also supports clinical and scientific discussions, patient safety and eligibility, quality-event remediation, and audit-related corrective and preventive actions when applicable. Travel of 60–80% is required.

Requirements

• At least 2 years of relevant clinical research site monitoring experience.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local country regulations.
• Fluency in English and the native language(s) of the country where the employee will work.
• Ability to travel 60–80%.
• Valid driver’s license and passport.
• Bachelor’s degree in life sciences, or a professional degree in a life-sciences field such as nursing, pharmacy, or medicine, or equivalent.

Responsibilities

• Ensure clinical trials are conducted according to the Study Monitoring Plan (SMP), applicable laws, GCP, and Sponsor standards.
• Manage assigned operational aspects of trial activities at investigator sites from activation through database lock, meeting timelines and quality requirements.
• Serve as the primary point of contact for assigned investigator sites during study conduct and partner with or escalate issues to the Site Care Partner.
• Facilitate information flow among the study team, vendors, and investigator sites.
• Partner with the Site Care Partner to develop sites and coach and train site personnel on protocol compliance and patient safeguards.
• Provide protocol training and address site staff questions, including discussion of operational and clinical trial risks.
• Attend investigator meetings when required and support enrollment, site activation, recruitment, and site-level recruitment initiatives.
• Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure in accordance with the SMP and Standard Operating Procedures.
• Monitor site-level adverse events and serious adverse events, collaborate with the Drug Safety Unit, and follow up with sites to resolve SAE reporting requirements.
• Submit required reports, documentation, updates, and tracking within required timeframes, including TMF documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics.
• Identify and resolve investigator site issues; agree and develop corrective and preventive actions with investigators and site personnel.
• Resolve data queries within required timelines and prepare and conduct investigator site close-out activities within required timelines.
• Oversee investigational product at investigator sites, including receipt, handling, accounting, storage conditions, and destruction.
• Support database release as needed.
• Undertake unblinded monitor responsibilities where appropriate.
• Maintain detailed understanding of the product, protocol, and therapy area to support discussions with investigators and site teams.
• Interact with investigator-site healthcare professionals in a manner that supports the Sponsor’s credibility, scientific leadership, and clinical development goals.
• Support the study clinician in patient safety, eligibility, and clinical guidance to investigators.
• Drive Quality Event remediation when applicable.
• Serve as a point of contact for audits and drive audit-observation CAPA development and checks when applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level