Sr. Clinical Research Associate - 177757

Piper Companies; United States; Remoto; USD 140.000 - 150.000; Tempo integral

Resumo da vaga

Piper Companies is seeking a Senior Clinical Research Associate (CRA) to join a leading CRO supporting Oncology trials along the East Coast. The Senior CRA will independently manage investigative sites, monitor visits, and ensure patient safety, data integrity, and compliance with ICH-GCP and study protocols.

Requirements include 3+ years independent clinical monitoring, Oncology trial experience, and strong knowledge of ICH-GCP and FDA regulations.

Qualificações

• 3+ years of independent clinical monitoring experience.
• Oncology clinical trial monitoring experience required.
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
• Experience managing multiple investigative sites independently.
• Strong communication, organization, and site management skills.
• East Coast based with ability to travel to investigative sites as required.

Responsabilidades

• Independently manage investigative sites from initiation through closeout.
• Conduct onsite and remote monitoring visits, including SIVs, IMVs, and COVs.
• Perform source data review/verification and ensure data quality and protocol compliance.
• Monitor site performance, enrollment, deviations, queries, and AE/SAE documentation.
• Maintain accurate study documentation within CTMS, EDC, eTMF, and site files.
• Build strong relationships with investigators and site staff while identifying and escalating study risks.

Conhecimentos

Independent monitoring

Oncology monitoring

ICH-GCP knowledge

FDA regulations knowledge

Site management

Descrição da vaga

Piper Companies is seeking a Senior Clinical Research Associate (CRA) to join a leading clinical research organization supporting Oncology clinical trials throughout the East Coast. This role will independently manage investigative sites while ensuring patient safety, data integrity, and compliance with ICH-GCP and study protocols.

Responsibilities of the Senior Clinical Research Associate:

• Independently manage investigative sites from initiation through closeout.
• Conduct onsite and remote monitoring visits, including SIVs, IMVs, and COVs.
• Perform source data review/verification and ensure data quality and protocol compliance.
• Monitor site performance, enrollment, deviations, queries, and AE/SAE documentation.
• Maintain accurate study documentation within CTMS, EDC, eTMF, and site files.
• Build strong relationships with investigators and site staff while identifying and escalating study risks.

Qualifications of the Senior Clinical Research Associate:

• 3+ years of independent clinical monitoring experience.
• Oncology clinical trial monitoring experience required.
• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
• Experience independently managing multiple investigative sites.
• Strong communication, organization, and site management skills.
• East Coast based with ability to travel to investigative sites as required.

Compensation of the Senior Clinical Research Associate:

• Salary: $140,000–$150,000 annually
• Reginal Travel Required
• Comprehensive Benefits: Medical, Dental, Vision, 401(k), Sick Leave (as required by law), and Paid Holidays

Application Period:

This position opens for applications on 10/12/2026 and will remain open for a minimum of 30 days from the posting date.

Keywords:

Clinical Research Associate, CRA, Senior CRA, Oncology, Clinical Monitoring, Site Monitoring, ICH-GCP, CTMS, EDC, eTMF, SDV, SDR, SIV, IMV, Clinical Operations

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