Clinical Trials Compliance & Submissions Specialist I

Stanford University; Palo Alto (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support across a diverse clinical research portfolio. The role guides teams through HRPP/IRB processes and ensures compliance from concept to activation.

Responsibilities include training investigators, maintaining SOPs, and coordinating regulatory updates while supporting safety reporting and audit readiness.

Qualifications

• Bachelor’s degree and three years of related experience.
• Experience in clinical trials operations or working with an IRB.
• Knowledge of FDA regulations and Good Clinical Practice.
• Excellent written and verbal communication; strong attention to detail.
• Proficiency with MS Office and database applications.

Responsibilities

• Independently develop, draft and compile research protocoldocuments and all materials required for regulatory submissions incompliance with University and external policies.
• Manage and oversee new study initiation process, includingeducating study staff and sponsors, resolving issues and providingregulatory guidance and support.
• Facilitate and participate in committee meetings, ensureprocedures are followed. Responsible for compiling, organizing, andstoring all session documentation and communicating results asappropriate.
• Revise submissions for identified problems and issues and resolveany procedural issues that might arise in order to ensure timelyresponse; advise investigator on remedies and revisions.
• Maintain regulatory documents, monitor and recommend improvementsfor tracking regulatory documents. May assist with registering andreporting of clinical trials, i.e. ClinicalTrials.gov.
• Collaborate on development of standard operating procedures,trainings, and documentation. May participate in deliveringtrainings.
• Stay current on federal, state, and local regulations regardingclinical research and communicate changes to study staff and recommendrelated changes to leadership.
• May serve as primary liaison on safety issues and reportingprocedures with the IRB, OSR, RMG or other internal organizations orcommittees.
• May co-author committee responses to investigators, assure theseare reviewed, signed by the Chairperson, and communicated promptly tothe necessary parties.

Skills

Regulatory knowledge

IRB experience

Communication skills

MS Office

Clinical trials operations

FDA regulations

Good Clinical Practice

Writing skills

Education

Bachelor’s degree

Tools

ClinicalTrials.gov

Job description

Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support across a diverse clinical research portfolio. The role guides teams through HRPP/IRB processes and ensures compliance from concept to activation.

Responsibilities include training investigators, maintaining SOPs, and coordinating regulatory updates while supporting safety reporting and audit readiness.