Remote Senior Clinical Research Associate — Site Leadership

Parexel; Dover (DE); On-site; USD 90,000 - 120,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate I (Sr. CRA) to manage investigator sites, monitor studies from activation to close-out, and ensure patient safety and data quality in accordance with GCP and SMP.

Significant travel (60-80%) and strong site relationships are required. You will work with the Site Care Partner and study team to train site staff, address protocol questions, support enrollment, monitor AEs/SAEs, and ensure timely TMF documentation and reporting.

Qualifications

• Minimum 3 years in clinical research monitoring (2 years oncology preferred).
• Experience with global trials and site management.
• Fluent in English; knowledge of local country language is a plus.

Responsibilities

• Oversee monitoring and study conduct per SMP and GCP.
• Manage site activation through database lock with timelines.
• Serve as primary site contact; coordinate with SCP.
• Facilitate information flow between study team, vendors and sites.
• Provide investigator site development and training on protocol.
• Attend investigator meetings and support recruitment initiatives.
• Monitor AEs/SAEs and ensure timely reporting.
• Submit TMF docs and site reports within timeframes.

Skills

Clinical trial methodologies

ICH-GCP knowledge

FDA regulations

Oncology monitoring experience

Fluent English

Travel readiness

Driver's license

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Senior Clinical Research Associate I (Sr. CRA) to manage investigator sites, monitor studies from activation to close-out, and ensure patient safety and data quality in accordance with GCP and SMP.

Significant travel (60-80%) and strong site relationships are required. You will work with the Site Care Partner and study team to train site staff, address protocol questions, support enrollment, monitor AEs/SAEs, and ensure timely TMF documentation and reporting.