Senior Clinical Research Associate - Remote

Parexel; Frankfort (KY); A distancia; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Parexel is seeking a Clinical Research Associate (CRA) to oversee site management, monitoring, and close-out for assigned investigator sites in compliance with GCP and sponsor standards. The CRA will ensure patient safety and data integrity, coordinating with the Site Care Partner and study team for enrollment, database release, and site performance.

The role requires 2+ years of monitoring experience, strong knowledge of ICH/GCP, and the ability to travel 60-80%.

Formación

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Monitoring experience: minimum 2 years relevant experience in clinical research site monitoring.
• Must be fluent in English and in the native language(s) of the country they will work in.
• Ability to travel 60-80%
• Valid driver's license and passport required
• Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Responsabilidades

• Ensure proper conduct of clinical trials in accordance with the SMP, laws, GCP, and sponsor standards to achieve goals.
• Manage site activation through database lock with quality deliverables.
• Serve as primary contact for investigator sites and coordinate with SCP.
• Interface with the study team to ensure smooth information flow and site delivery.
• Provide investigator site training and address protocol-related questions.
• Attend investigator meetings and support recruitment initiatives at site level.
• Conduct onsite, remote/electronic monitoring as needed for initiation, monitoring and close-out.
• Monitor AEs/SAEs and collaborate with Drug Safety for resolution.
• Submit TMF, site reports, protocol deviations and recruitment metrics within timelines.
• Identify and resolve site issues with CAPA where applicable.
• Close-out plan and activities for investigators; oversee investigational product handling.
• Maintain oversight of product at sites and support database release.

Conocimientos

Clinical trial knowledge

Monitoring experience

English fluency

Travel ready

Educación

Bachelor's degree in life sciences or equivalent

Descripción del empleo

Parexel is seeking a Clinical Research Associate (CRA) to oversee site management, monitoring, and close-out for assigned investigator sites in compliance with GCP and sponsor standards. The CRA will ensure patient safety and data integrity, coordinating with the Site Care Partner and study team for enrollment, database release, and site performance.

The role requires 2+ years of monitoring experience, strong knowledge of ICH/GCP, and the ability to travel 60-80%.