Senior Clinical Research Associate (CRA) - 177680

Piper Companies; United States; Vor Ort; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision coverage

Retirement plans

Zusammenfassung

Piper Companies is seeking a Senior Clinical Research Associate (CRA) to support a leading organization in clinical research and biotechnology. The Senior CRA will oversee trial sites, ensure compliance with study protocols and regulatory guidelines, and support trial execution across oncology, cardiology, medical technology and other complex areas.

Responsibilities include on-site and remote monitoring, reviewing source documents and data quality, identifying risks and deviations, and

Qualifikationen

• 3+ years CRA experience in CRO/pharma/medical device environments.
• Bachelor’s degree in a scientific/healthcare field.
• Ability to travel 10–12 days per month for on-site monitoring.
• Strong knowledge of ICH-GCP guidelines and FDA regulations.
• Experience monitoring oncology studies preferred.

Aufgaben

• Conduct on-site and remote monitoring visits to ensure compliance with study protocols and regulatory requirements.
• Review site performance, source documentation, and data quality to maintain trial integrity and participant safety.
• Identify risks, protocol deviations, and operational challenges; implement corrective actions as needed.
• Partner with investigators, site staff, and cross-functional teams to support enrollment, study execution, and inspection readiness.
• Mentor junior CRAs and guide sites on best practices and quality standards.
• Assist with audit preparation, CAPA activities, and ongoing process improvement initiatives.

Kenntnisse

Communication skills

Organizational skills

Relationship management

Ausbildung

Bachelor's degree in a scientific/healthcare field

Jobbeschreibung

Piper Companies is seeking a Senior Clinical Research Associate (CRA) to support a leading organization within the clinical research and biotechnology industry. The Senior Clinical Research Associate (CRA) will be responsible for overseeing clinical trial sites, ensuring compliance with study protocols and regulatory guidelines, and supporting successful trial execution across a variety of therapeutic areas, including oncology, cardiology, medical technology, and other complex focuses.

Responsibilities of the Senior Clinical Research Associate (CRA):

• Conduct on-site and remote monitoring visits to ensure compliance with study protocols, GCP guidelines, and specific regulatory requirements.
• Review site performance, source documentation, and data quality to maintain trial integrity and participant safety.
• Identify potential risks, protocol deviations, and operational challenges, implementing corrective actions when necessary.
• Partner with investigators, site staff, and cross-functional teams to support enrollment, study execution, and inspection readiness.
• Mentor junior CRAs and provide guidance to research sites on best practices and quality standards.
• Assist with audit preparation, CAPA activities, and ongoing process improvement initiatives.

Qualifications of the Senior Clinical Research Associate (CRA):

• 3+ years of Clinical Research Associate (CRA) experience within a CRO, pharmaceutical, biotechnology, or medical device environment.
• Bachelor's degree required in a scientific, healthcare, or related discipline.
• Ability to travel approximately 10-12 days per month for on-site monitoring activities.
• Strong understanding of ICH-GCP guidelines, FDA regulations, and clinical trial operations.
• Experience monitoring oncology studies preferred; candidates with experience in other complex therapeutic areas will also be considered.
• Excellent communication, organizational, and relationship-management skills.

Compensation for the Senior Clinical Research Associate (CRA) includes:

• Salary range: $110,000 - $150,000 depending on experience
• Comprehensive benefits package including medical, dental, vision, and retirement plans
• Location: West/West Coast based

This job opens for applications on 11/2/2026. Applications for this job will be accepted for at least 30 days from the posting date.

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