Clinical Trials Principal Investigator — Flexible Hours

Denali Health; Portland (OR); Hybrid; USD 140,000 - 220,000; Full time

Benefits offered by this job

Flexible work arrangements

Adaptable scheduling

Job summary

Denali Health in Portland, OR seeks a dedicated Principal Investigator to lead and manage clinical research studies. The PI will oversee study design, execution, safety, and regulatory compliance, ensuring integrity and patient safety across trials.

Responsibilities include protocol review, start-up documentation, sponsor meetings, and safety monitoring. Ideal candidates hold an MD/DO, GCP certification, and 2+ years as PI or Sub-Investigator, with strong leadership and communication skills.

Qualifications

• MD/DO required with clinical trial oversight experience.
• GCP, FDA regulations, and IRB familiarity.
• Board certification preferred but not required for all candidates.

Responsibilities

• Review protocol and capabilities; provide sponsor feedback on study design.
• Sign off on start-up docs including Investigator Brochure and FDA Form 1572.
• Lead initiation meetings with sponsor and oversee site qualifications.
• Explain study details to participants and obtain informed consent.
• Monitor safety data; assess adverse events and SAEs; ensure compliance.
• Review CRFs, finalize Clinical Study Reports, and ensure data integrity.
• Develop SOPs and training plans; support emergency response procedures.
• Develop physician specialist network for referrals and study support.
• Represent Denali Health at sponsor meetings and conferences.

Skills

Leadership

GCP knowledge

FDA regulations

IRB processes

Communication

Team management

Multilingual

Education

MD/DO

PhD considered

Board certification

GCP certification

Job description

Denali Health in Portland, OR seeks a dedicated Principal Investigator to lead and manage clinical research studies. The PI will oversee study design, execution, safety, and regulatory compliance, ensuring integrity and patient safety across trials.

Responsibilities include protocol review, start-up documentation, sponsor meetings, and safety monitoring. Ideal candidates hold an MD/DO, GCP certification, and 2+ years as PI or Sub-Investigator, with strong leadership and communication skills.