Senior CRA II - Remote SE US Clinical Trials

Jobtome; Myrtle Point (OR); Hybrid; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Jobtome is seeking a Clinical Research Associate (Level II) to coordinate all aspects of clinical monitoring and site management. The role includes performing remote or on-site visits, ensuring protocol and regulatory compliance, and maintaining essential documentation across sponsor environments.

The candidate will manage communications with investigational sites and provide status updates to the Clinical Team Manager, while contributing to process improvements and project publications.

Qualifikationen

• Bachelor’s degree in life sciences or nursing (or equivalent).
• 1 year of clinical research monitoring experience or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.

Aufgaben

• Monitor sites using risk-based monitoring; perform RCA and SDR/SDV as applicable.
• Coordinate investigator meetings and initiate qualified investigative sites.
• Ensure essential documents are complete per ICH-GCP and regulations; conduct on-site file reviews.
• Provide trial status updates to the Clinical Team Manager and keep study systems updated.
• Communicate with sites, client and project team; respond to audits/inspections.
• Maintain administrative tasks such as expense reports and timesheets.
• Contribute to project publications/tools and process improvements.

Kenntnisse

Clinical monitoring

English communication

Documentation

Microsoft Office

Presentation skills

Ausbildung

Bachelor’s degree in life sciences or nursing

Tools

MS Office

Jobbeschreibung

Jobtome is seeking a Clinical Research Associate (Level II) to coordinate all aspects of clinical monitoring and site management. The role includes performing remote or on-site visits, ensuring protocol and regulatory compliance, and maintaining essential documentation across sponsor environments.

The candidate will manage communications with investigational sites and provide status updates to the Clinical Team Manager, while contributing to process improvements and project publications.