Remote Senior CRA I - Cardiovascular & CNS Trials

Piper Companies; United States; A distancia; USD 125.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

Sick leave (as required by law)

401(k)

Descripción de la vacante

Piper Companies is seeking a Senior Clinical Research Associate I for a remote permanent role with 60-75% travel to sites across the United States. The Senior CRA I will monitor cardiovascular, CNS, and metabolic studies, collaborating closely with investigative sites to ensure high-quality trial execution.

The role requires 1–4 years of onsite monitoring experience and a strong working knowledge of GCP/ICH and FDA regulations.

Formación

• 1–4 years of onsite clinical monitoring experience.
• Experience supporting trials in cardiovascular, CNS, diabetes, or metabolic indications.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations.
• Proficiency with CTMS, EDC systems, and standard trial documentation.
• Bachelor’s degree in life sciences or nursing; Spanish fluency preferred for candidates based in Florida or Puerto Rico.

Responsabilidades

• Perform routine and close-out monitoring visits ensuring studies align with GCP/ICH and regulations.
• Serve as primary site contact, fostering relationships and ongoing communication.
• Review site data, source documents, and regulatory files for accuracy and protocol adherence.
• Provide guidance and training to site staff on protocol requirements and study procedures.
• Identify, document, and escalate quality or compliance concerns and support resolution.

Conocimientos

Site monitoring

GCP knowledge

ICH guidelines

FDA regulations

CTMS

EDC systems

Regulatory compliance

Site communication

Educación

Bachelor’s in life sciences

Nursing

Herramientas

CTMS

EDC systems

Descripción del empleo

Piper Companies is seeking a Senior Clinical Research Associate I for a remote permanent role with 60-75% travel to sites across the United States. The Senior CRA I will monitor cardiovascular, CNS, and metabolic studies, collaborating closely with investigative sites to ensure high-quality trial execution.

The role requires 1–4 years of onsite monitoring experience and a strong working knowledge of GCP/ICH and FDA regulations.