Clinical Research Associate II - All US Locations - FSP
About The Position
The Clinical Research Associate (CRA) is responsible for site management, monitoring, and close-out of assigned clinical trial investigator sites, ensuring patient safety and quality study execution in accordance with applicable laws, Good Clinical Practices (GCP), and Sponsor standards. The CRA manages investigator site relationships and operational aspects of trial delivery, supports enrollment and database release, safeguards site quality and compliance, and maintains investigator and site staff engagement. The role resolves protocol-related issues and works closely with the Site Care Partner (SCP) and study team throughout site set-up, conduct, and close-out. The CRA oversees assigned sites from activation through database lock, conducts onsite and remote monitoring, supports site personnel training and recruitment, and monitors adverse event reporting. The role also handles required study documentation and reporting, query resolution, investigational product oversight, site issue remediation, and close-out activities. Additional responsibilities may include unblinded monitoring, audit support, and quality event remediation.
Requirements
- Minimum 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 life sciences 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 operational aspects of trial implementation at assigned investigator sites from activation through database lock, meeting timelines and quality requirements.
- Serve as the primary contact for assigned investigator sites and partner with or escalate issues to the Site Care Partner (SCP).
- Facilitate information flow among the study team, vendors, and investigator sites.
- Partner with the SCP to develop sites and coach and train site personnel on protocol compliance and patient safeguarding.
- Provide protocol training and address site staff protocol questions, including discussion of operational and clinical trial risks.
- Attend investigator meetings when required, provide enrollment support, and work with the SCP and study team on site-level recruitment initiatives.
- Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure in accordance with the SMP and SOPs.
- Monitor site-level adverse events (AEs) and serious adverse events (SAEs), collaborate with the Drug Safety Unit, and follow up with sites to resolve required SAE report information.
- Submit required reports, documentation, updates, and tracking on time, including TMF documentation, site reports and follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics.
- Identify and resolve site issues within required timeframes; agree on 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.
- Oversee investigational product receipt, handling, accounting, storage conditions, and destruction at investigator sites.
- Support database release as needed.
- Undertake unblinded monitor responsibilities when appropriate.
- Maintain sufficient understanding of the product, protocol, and therapy area to engage appropriately with investigators and site teams.
- Interact with investigator-site health care professionals to support 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
