CRA II/Sr. CRA – Remote & On-site Monitoring

Regulatory Jobs; Texas; Sur place; USD 65 000 - 105 000; Plein temps

Résumé du poste

Regulatory Jobs in the United States seeks a Clinical Research Associate (Level II) to oversee monitoring and site management. You will conduct remote or on-site visits, ensure protocol and regulatory compliance, and manage essential documents across multiple sponsors and environments.

The role requires strong clinical monitoring skills, knowledge of ICH-GCP, and the ability to communicate with investigative sites and project teams. Travel and documentation excellence are essential.

Qualifications

• Bachelor's degree in life sciences or nursing equivalency.
• 1 year clinical research monitor experience or PPD Fellowship.
• Valid driver's license where applicable.

Responsabilités

• Monitor investigator sites with risk-based monitoring, SDR/SDV review, and on-site/remote monitoring.
• Ensure documents are complete, compliant with ICH-GCP and SOPs.
• Provide trial status updates to the Clinical Team Manager and maintain study systems.
• Coordinate site initiation, monitoring visits and close-out activities.
• Communicate effectively with sites, sponsors, and project team members.

Connaissances

Clinical monitoring

ICH-GCP knowledge

Regulatory compliance

Critical thinking

Communication

Documentation

Team player

MS Office

English proficiency

Formation

Bachelor's degree in Life Sciences

Outils

CTMS

Regulatory databases

Description du poste

Regulatory Jobs in the United States seeks a Clinical Research Associate (Level II) to oversee monitoring and site management. You will conduct remote or on-site visits, ensure protocol and regulatory compliance, and manage essential documents across multiple sponsors and environments.

The role requires strong clinical monitoring skills, knowledge of ICH-GCP, and the ability to communicate with investigative sites and project teams. Travel and documentation excellence are essential.