Senior CRA / Clinical Trial Monitor

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 is hiring a Remote, Senior CRA / Clinical Trial Monitor. Package includes competitive rate and benefit options.

Education

Bachelor's degree in a life science, nursing or health-related field; clinical research certification (CCRA, CCRP) preferred.

Experience

Minimum of 5 years of clinical monitoring experience, with at least 3 years on NIH- or FDA-regulated trials.

Qualifications

• Hands-on experience conducting site initiation, interim monitoring and close-out visits, on-site and remote
• Expertise in source document verification, informed consent review, and protocol and GCP compliance assessment
• Experience reviewing adverse event and serious adverse event documentation and reporting
• Experience with investigational product accountability, storage and reconciliation
• Ability to write clear monitoring reports, identify deficiencies, and develop and track corrective and preventive actions (CAPA)
• Willingness and ability to travel as required
• Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
• Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
• Current human subjects protections and GCP training (e.g., CITI or equivalent)
• Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.