Clinical Research Associate II/III — Site Oversight & Trial Coordination

Novotech; Chicago (IL); On-site; USD 70,000 - 140,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Circle Back Initiative Employer

Job summary

Novotech is seeking a Clinical Research Associate (CRA) to safeguard trial participant rights and ensure accurate, complete trial data. The CRA acts as primary liaison among investigative sites, Novotech, and sponsors, ensuring trials align with ICH GCP and regulatory SOPs.

The role focuses on building site relationships, supporting regulatory submissions, monitoring sites (onsite or remote), and driving recruitment while maintaining high data quality and trial integrity.

Qualifications

• Bachelor's degree in clinical or life sciences; other allied fields may be considered.
• Strong time management, attention to detail; team oriented and computer literate.

Responsibilities

• Build relationships with Principal Investigators, study staff and site personnel to ensure efficient trial management.
• Foster internal and external relationships to support timely project delivery.
• Support site essential documents preparation and ethics/regulatory submissions as needed.
• Understand regulatory requirements for local and international trials relevant to the studies.
• Coordinate site recruitment and engagement efforts and implement recruitment plans.
• Monitor investigational sites per ICH GCP and CMP; conduct on-site or remote visits as required.
• Ensure rights and safety of participants; manage consent checks, eligibility, protocol adherence, and AE/SAE reporting.
• Verify data accuracy and resolve CRF queries per monitoring plans.
• Ensure proper storage, dispensing and reconciliation of study drug as per protocol.

Skills

Site coordination

ICH-GCP

Regulatory knowledge

Data verification

Education

Bachelor's degree in life sciences

Job description

Novotech is seeking a Clinical Research Associate (CRA) to safeguard trial participant rights and ensure accurate, complete trial data. The CRA acts as primary liaison among investigative sites, Novotech, and sponsors, ensuring trials align with ICH GCP and regulatory SOPs.

The role focuses on building site relationships, supporting regulatory submissions, monitoring sites (onsite or remote), and driving recruitment while maintaining high data quality and trial integrity.