Senior Oncology Clinical Research Associate (Remote)

Parexel International; France; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Clinical Research Associate (SCRA) to join our France-based team in a remote/home-based capacity. You will oversee monitoring across investigator sites, ensuring data integrity, patient safety, and regulatory compliance in sponsor-dedicated trials, with a focus on oncology and RECIST criteria.

You will collaborate with site personnel, investigators, and project teams to support study delivery, using a mix of remote and on-site monitoring to keep studies

Qualifications

• Bachelor’s degree, RN or equivalent.
• Experience in clinical research monitoring with oncology trials and RECIST knowledge.
• Knowledge of ICH-GCP, regulatory requirements, and trial processes.
• Experience conducting on-site and remote monitoring activities.
• Strong communication, organizational, and interpersonal skills.
• Ability to build relationships with investigator sites and stakeholders.

Responsabilités

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites.
• Evaluate site performance and provide recommendations for actions and corrective actions.
• Verify informed consent processes are conducted and documented.
• Assess patient safety and data integrity by identifying protocol deviations and pharmacovigilance concerns.
• Conduct monitoring activities via remote and on-site methods per plans.
• Perform source data verification and ensure CRFs match source docs.
• Manage protocol deviation reporting and data queries resolution.
• Review investigational product handling and documentation where applicable.
• Document monitoring findings through reports, letters, and logs.
• Ensure activities are performed by trained site personnel.
• Maintain tracking of observations, status, and progress in systems.
• Review site documentation and training to ensure inspection readiness.
• Participate in investigator, sponsor, and project team meetings.
• Collaborate with Site Manager to support objectives and timelines.

Connaissances

Networking

Relationship building

Stakeholder management

Clinical research

Oncology trials

RECIST knowledge

ICH-GCP

Monitoring (on-site/remote)

Communication

Data integrity

Site coordination

Regulatory awareness

Formation

Bachelor’s degree or RN

Description du poste

Parexel is seeking a Senior Clinical Research Associate (SCRA) to join our France-based team in a remote/home-based capacity. You will oversee monitoring across investigator sites, ensuring data integrity, patient safety, and regulatory compliance in sponsor-dedicated trials, with a focus on oncology and RECIST criteria.

You will collaborate with site personnel, investigators, and project teams to support study delivery, using a mix of remote and on-site monitoring to keep studies