CRA II / Senior CRA — Remote & On-Site Monitoring Pro

Jobtome; Chicago (IL); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Jobtome seeks a Clinical Research Associate (Level II) to join their global team. You will perform remote or on-site visits to monitor protocol and regulatory compliance, manage essential documentation, and coordinate with sponsors across various monitoring environments.

The role requires 1–2 years of on-site monitoring experience, ability to travel up to 80%, and full work authorization in the United States. You will help ensure patient safety, data integrity, and audit readiness.

Qualifikationen

• Bachelor's degree in a life sciences field or RN certification or equivalent.
• 1–2 years on-site monitoring experience with up to 80% travel.
• Must be legally authorized to work in the United States without sponsorship.
• Must pass a comprehensive background check and drug screening.

Aufgaben

• Monitor investigator sites using a risk-based monitoring approach to ensure protocol compliance and drive action.
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters promptly using approved standards.
• Escalate deficiencies to clinical management and follow issues through to resolution.
• Participate in investigator meetings and site initiations as needed.
• Maintain study systems and provide status updates to the Clinical Team Manager.

Kenntnisse

Clinical monitoring

Regulatory knowledge

ICH GCP

Data review

Documentation

Ausbildung

Bachelor's degree in life sciences

RN certification

Relevant clinical research experience

Tools

Microsoft Office

Jobbeschreibung

Jobtome seeks a Clinical Research Associate (Level II) to join their global team. You will perform remote or on-site visits to monitor protocol and regulatory compliance, manage essential documentation, and coordinate with sponsors across various monitoring environments.

The role requires 1–2 years of on-site monitoring experience, ability to travel up to 80%, and full work authorization in the United States. You will help ensure patient safety, data integrity, and audit readiness.