Senior Oncology Clinical Research Associate - Remote

Parexel; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SCRA) to advance oncology trials in a remote/home-based capacity. You will monitor sites, ensure data integrity, safety, and regulatory compliance, collaborating with investigators and project teams to support study delivery.

You will leverage RECIST expertise to support study execution, maintain inspection readiness, and drive high-quality outcomes for patients in a sponsor-dedicated model.

Qualifications

• Experience in clinical research monitoring, oncology trials, and RECIST.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Excellent written and verbal communication and presentation skills.

Responsibilities

• Ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures across assigned sites.
• Evaluate site performance and provide recommendations for site-specific actions and corrective actions.
• Verify informed consent processes are appropriately conducted and documented.
• Assess patient safety and data integrity by identifying protocol deviations and pharmacovigilance concerns.
• Conduct monitoring activities through remote and on-site methods per monitoring plans.
• Perform source data review and ensure CRF data is accurate and supported by source docs.
• Manage protocol deviation reporting, follow-up, and data-query resolution.
• Review investigational product accountability, storage, and related documentation.
• Document monitoring findings through reports and logs.
• Ensure study activities are performed by trained site personnel.

Skills

Networking & relationship-building

Stakeholder management

Communication skills

RECIST criteria knowledge

Clinical research monitoring

Education

Bachelor’s degree, RN

Job description

Parexel is seeking a Senior Clinical Research Associate (SCRA) to advance oncology trials in a remote/home-based capacity. You will monitor sites, ensure data integrity, safety, and regulatory compliance, collaborating with investigators and project teams to support study delivery.

You will leverage RECIST expertise to support study execution, maintain inspection readiness, and drive high-quality outcomes for patients in a sponsor-dedicated model.