Senior Oncology Clinical Research Associate, Remote

Parexel; United States; Teletrabalho; USD 45 000 - 79 000; Tempo parcial

Resumo da oferta

Parexel is seeking a Senior Clinical Research Associate (0.5 FTE) to join our team in Belgium in a remote/home-based capacity. You will oversee monitoring across investigator sites, ensuring data integrity, patient safety, and regulatory compliance in oncology trials within a sponsor-dedicated model.

The role leverages RECIST expertise to support study execution through a mix of remote and on-site monitoring, while maintaining inspection readiness and high-quality outcomes for patients.

Qualificações

• Experience in clinical research monitoring with oncology trial experience and RECIST knowledge.
• Ability to navigate ICH-GCP, regulatory requirements, and trial processes.
• Strong communication, organization, and interpersonal skills.

Responsabilidades

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites.
• Evaluate site performance and recommend actions, escalate issues, and support corrective actions.
• Verify informed consent processes are conducted and documented for each participant.
• Assess patient safety and data integrity by identifying protocol deviations and pharmacovigilance concerns.
• Conduct monitoring activities through remote and on-site methods per plans.
• Perform source document verification and ensure CRFs align with source data.
• Manage protocol deviation reporting and data query resolution.
• Review investigational product accountability and related documentation.
• Document monitoring findings through reports, letters, and logs.
• Ensure activities are performed by trained site personnel and tracked in systems.
• Review site documentation to maintain inspection readiness.
• Participate in investigator, sponsor, and monitoring meetings.

Conhecimentos

Clinical research monitoring

Oncology trials

RECIST criteria

Regulatory compliance

Stakeholder management

Formação académica

Bachelor’s degree, RN or equivalent

Descrição da oferta de emprego

Parexel is seeking a Senior Clinical Research Associate (0.5 FTE) to join our team in Belgium in a remote/home-based capacity. You will oversee monitoring across investigator sites, ensuring data integrity, patient safety, and regulatory compliance in oncology trials within a sponsor-dedicated model.

The role leverages RECIST expertise to support study execution through a mix of remote and on-site monitoring, while maintaining inspection readiness and high-quality outcomes for patients.