Spec 3, Clinical Research
Kaygen, Inc. · Irvine, CA · 1 wk ago
On-siteResearchContract
Key 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.
- Aid in 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.
Requirements
Not specified
Qualifications
Not specified
Skills
Not specified
Benefits
Free Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Sick Time Off
Pay
Not specified
Schedule
Not specified