Remote Clinical Trials Regulator & Compliance Lead

Stanford University; Palo Alto (CA); Remote; USD 90,000 - 130,000; Full time

Job summary

Stanford University’s Division of Body MRI seeks a Clinical Trials Regulator Specialist to coordinate regulatory planning and commercialization for ARPA-H LIGHT projects on MRI lymphatic imaging.

You will manage IRB submissions, regulatory roadmaps, and sponsor communications; assist in proposal documentation, milestones, and billing; and ensure compliance with FDA regulations and Good Clinical Practice. This is a remote opportunity.

Qualifications

• Bachelor’s degree and three years of related experience.
• Excellent communication skills and superb attention to detail.
• Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
• Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Strong writing skills.

Responsibilities

• Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
• Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
• Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
• Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
• Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e., ClinicalTrials.gov.
• Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings.
• Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership.
• May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
• May co-author committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.

Skills

Communication skills

Attention to detail

Interpersonal skills

Regulatory knowledge

Strong writing skills

Education

Bachelor’s degree and 3 years related experience

Tools

MS Office

Database applications

Job description

Stanford University’s Division of Body MRI seeks a Clinical Trials Regulator Specialist to coordinate regulatory planning and commercialization for ARPA-H LIGHT projects on MRI lymphatic imaging.

You will manage IRB submissions, regulatory roadmaps, and sponsor communications; assist in proposal documentation, milestones, and billing; and ensure compliance with FDA regulations and Good Clinical Practice. This is a remote opportunity.