Senior Remote Clinical Trial Monitor (NIH/FDA Regulated)

Saratoga Ascend; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Saratoga Medical Center, Inc. is seeking a Remote, Senior CRA / Clinical Trial Monitor to oversee NIH- and FDA-regulated trials across sites. This role requires a life sciences degree and a clinical research certification is preferred.

You should have 5+ years of monitoring experience, including 3+ years in regulated trials, with strong GCP and regulatory knowledge. The position supports site initiation, monitoring, and close-out visits, both on-site and remote, ensuring accurate documentation

Qualifications

• Require a life science or health-related bachelor's degree.
• Clinical research certification is preferred but not mandatory.
• Minimum 5 years of clinical monitoring experience, with 3+ years in NIH- or FDA-regulated trials.
• Ability to perform site visits on-site and remotely.
• Strong knowledge of GCP, HIPAA, and related regulations.

Responsibilities

• Conduct site initiation, interim monitoring and close-out visits (on-site and remote).
• Verify source documents, review informed consent, and assess protocol and GCP compliance.
• Review and report adverse events and serious adverse events.
• Ensure investigational product accountability and reconciliation.
• Write monitoring reports, identify deficiencies and track CAPA.
• Willingness to travel as required.

Skills

Site initiation visits

Interim monitoring

Close-out visits

Source data verification

Informed consent review

GCP compliance

AE/SAE reporting

CAPA tracking

NIH/FDA-regulated trials

Travel flexibility

ICH E6 / CFR 21 Part 11 knowledge

HIPAA awareness

Education

Bachelor's degree in life sciences / health field

Clinical research certification (CCRA/CCRP) preferred

Job description

Saratoga Medical Center, Inc. is seeking a Remote, Senior CRA / Clinical Trial Monitor to oversee NIH- and FDA-regulated trials across sites. This role requires a life sciences degree and a clinical research certification is preferred.

You should have 5+ years of monitoring experience, including 3+ years in regulated trials, with strong GCP and regulatory knowledge. The position supports site initiation, monitoring, and close-out visits, both on-site and remote, ensuring accurate documentation