Spec 3, Clinical Research

KAYGEN•Irvine, CA

About The Position

The Clinical Research Specialist supports all phases of clinical studies, including study start-up, conduct, and closeout, with a primary focus on maintaining an audit- and inspection-ready Trial Master File (TMF). This role is responsible for organizing, reviewing, and maintaining clinical documentation within the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company Standard Operating Procedures (SOPs). The Specialist collaborates with cross-functional teams to resolve documentation and data issues, supports audit readiness, and contributes to continuous process improvements that enhance operational efficiency and documentation quality.

Requirements

Maintaining an audit- and inspection-ready Trial Master File (TMF).
Organizing, reviewing, and maintaining clinical documentation within the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).
Ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and company Standard Operating Procedures (SOPs).
Collaborating with cross-functional teams to resolve documentation and data issues.
Supporting audit readiness.
Contributing to continuous process improvements.
Supporting clinical trial start-up activities, including site readiness tracking, coordination of Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs), and communication with investigative sites.
Assisting with study conduct and closeout activities.
Reviewing essential Trial Master File (TMF) documents for completeness, accuracy, and compliance with GCP, company SOPs, and applicable U.S. and international regulatory requirements.
Performing quality checks on clinical documentation to ensure inspection readiness for regulatory and quality audits.
Identifying documentation inconsistencies, missing records, and compliance gaps.
Investigating issues and coordinating timely resolution with internal stakeholders.
Partnering with Clinical Data Management, Clinical Operations, and field teams to support data review, query management, and issue resolution.
Ensuring adherence to Good Documentation Practices (GDP) and maintaining accurate, organized, and audit-ready study records.

Nice To Haves

Experience with Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).

Responsibilities

Support clinical trial start-up activities, including site readiness tracking, coordination of Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs), and communication with investigative sites.
Assist with study conduct and closeout activities while ensuring all required documentation is complete and compliant.
Maintain, organize, and update study documentation within the eTMF and CTMS throughout the clinical trial lifecycle.
Review essential Trial Master File (TMF) documents for completeness, accuracy, and compliance with GCP, company SOPs, and applicable U.S. and international regulatory requirements.
Perform quality checks on clinical documentation to ensure inspection readiness for regulatory and quality audits, including FDA, PMDA, TUV, and other regulatory agencies.
Identify documentation inconsistencies, missing records, and compliance gaps; investigate issues and coordinate timely resolution with internal stakeholders.
Partner with Clinical Data Management, Clinical Operations, and field teams to support data review, query management, and issue resolution.
Participate in ongoing process evaluations and recommend improvements to enhance documentation quality, operational efficiency, and regulatory compliance.
Ensure adherence to Good Documentation Practices (GDP) and maintain accurate, organized, and audit-ready study records.
Support cross-functional collaboration to facilitate timely completion of clinical study deliverables.