Site Lead CRA I/II – Oncology Trials

Parexel; Tennessee; On-site; USD 70,000 - 100,000; Full time

Job summary

Parexel is seeking a Clinical Research Associate to lead site management across all phases of clinical studies. You will serve as the primary site contact, build and sustain strong site relationships, and ensure monitoring adheres to ICH-GCP and Sponsor SOPs.

Strong communication and regulatory documentation skills are essential. Ideal candidates have at least 2 years of direct site monitoring in bio/pharma/CRO, a life sciences degree, and readiness to travel 65–75% of the time.

Qualifications

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO.
• Knowledge of ICH-GCPs and regulatory expectations across regions.
• Experience coordinating with investigators and site staff to ensure protocol conformance.

Responsibilities

• Act as the primary site contact and site manager throughout all phases of a clinical study.
• Develops strong site relationships and maintains them through all trial phases.
• Performs monitoring activities in compliance with ICH-GCPs, Sponsor SOPs and local regulations.
• Gains understanding of the study protocol and related procedures.
• Coordinates tasks with sponsor roles to achieve Site Ready status.
• Performs remote and on-site monitoring with data accuracy and subject safety emphasis.
• Documents visit reports promptly and thoroughly.
• Manages regulatory documents for study start-up, maintenance and close-out.
• Communicates issues to Investigators and site staff and escalates as needed.
• Maintains information in the Clinical Trial Management System and related files.

Skills

Site management

Monitoring visits

GCP/ICH knowledge

Regulatory documentation

Data review

Communication skills

Trial management

Independent judgement

MS Office

Travel readiness

Education

Bachelor’s degree in life sciences

Job description

Parexel is seeking a Clinical Research Associate to lead site management across all phases of clinical studies. You will serve as the primary site contact, build and sustain strong site relationships, and ensure monitoring adheres to ICH-GCP and Sponsor SOPs.

Strong communication and regulatory documentation skills are essential. Ideal candidates have at least 2 years of direct site monitoring in bio/pharma/CRO, a life sciences degree, and readiness to travel 65–75% of the time.