Senior Clinical Trial Monitoring Lead — Remote

Parexel; Providence (RI); Remote; USD 95,000 - 145,000; Full time

Job summary

Parexel is seeking an experienced Clinical Research Associate to oversee monitoring activities across oncology and non-oncology trials. You will manage site activation, monitoring, and study conduct in collaboration with the SCP, ensuring adherence to SMP, GCP, and client standards.

The role requires travel (60-80%) within the area, strong knowledge of regulatory requirements, and excellent communication with sites and study teams. Fluency in English and travel readiness are essential.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA regulations.
• Experience in monitoring clinical trials and working with investigator sites.
• Fluency in English and local language(s) of the country.
• Ability to manage timelines, QA deliverables and site activities.

Responsibilities

• Oversee monitoring responsibilities and study conduct per SMP and applicable laws.
• Manage site activation through database lock and ensure quality deliverables.
• Serve as primary contact for investigator sites and coordinate with SCP for site delivery.
• Facilitate information flow among study team, vendors and sites.
• Provide training and protocol guidance to site personnel as required.
• Attend investigator meetings and support recruitment initiatives at site level.
• Conduct onsite or remote monitoring and ensure compliance with SOPs.
• Monitor AEs/SAEs and coordinate with Drug Safety for resolution.
• Submit required reports and maintain Trial Master File documentation.

Skills

Clinical trial methodologies

GCP & regulatory knowledge

Site monitoring

English fluency

Travel readiness

Communication skills

Problem solving

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking an experienced Clinical Research Associate to oversee monitoring activities across oncology and non-oncology trials. You will manage site activation, monitoring, and study conduct in collaboration with the SCP, ensuring adherence to SMP, GCP, and client standards.

The role requires travel (60-80%) within the area, strong knowledge of regulatory requirements, and excellent communication with sites and study teams. Fluency in English and travel readiness are essential.