Clinical Research Associate II/Senior Clinical Research Associate - All US Locations - FSP

About the role

The Clinical Research Associate (CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards.

Responsibilities

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met.
• Work in partnership with and/or escalate to the SCP to ensure quality of site delivery.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks.
• Attend investigator meetings when required (virtual or F2F).
• Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
• Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level.
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted according to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies.
• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team.
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators.
• Drive Quality Event (QE) remediation, when applicable.
• Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable.

Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations.
• Monitoring Experience: Minimum 2 years relevant experience in clinical research site monitoring.
• Fluent in English and in the native language(s) of the country they will work in.
• Valid driver’s license and passport required.

Qualifications

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.

Skills

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations.
• Monitoring Experience: Minimum 2 years relevant experience in clinical research site monitoring.
• Fluent in English and in the native language(s) of the country they will work in.
• Valid driver’s license and passport required.

Benefits

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.

Pay

TBD

Schedule

TBD