Highlights
We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries. 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.
Numbers & Facts
| Location | Irvine, CA |
| Industry | Computer/IT Services |
| Salary | $45–$46 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 2003 |
| Website | http://www.kaygen.com |
Description
KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.
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.
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.
- 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
At KAYGEN, people are at the heart of everything we do. We foster a diverse, inclusive, and employee-driven culture where every individual is valued, empowered, and encouraged to bring their authentic self to work. Our candidate-first approach means we are committed to understanding your career goals and connecting you with opportunities that align with your aspirations, skills, and potential. Whether you're taking the next step in your career or searching for your dream opportunity, KAYGEN is more than a staffing partner—we're a community dedicated to helping you grow, succeed, and thrive. Join us and discover a place where your talent is recognized, your ambitions are supported, and your future is built alongside a team that invests in your success every step of the way.
Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.
Benefits:
- Free Healthcare Insurance
- 401(k) Retirement Plan
- Free Life Insurance
- Sick Time Off
- Mentorship Program
- Certifications
- Referrals
- Family and Wellness benefits
- Continuous Growth and Career Development
Benefits
Paid Sick Days, Professional Development, 401K, Employee Referral Program, Flexible Spending Accounts, Employee Events, Life Insurance, Merchandise Discounts
About Company
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation. From structuring data to the Cloud and visualization, Kaygen leads the digital transformation of global clients.
Kaygen, from the Japanese word, kaizen, for continuous improvement, signifies how we continuously seek to bring expert tech talent to our client engagements to create a sustainable competitive advantage. However, there is more. Our company is diverse, and minority woman owned and operated by expert data technologists who have conceived and developed the very strategic technology initiatives that we now engage in for our clients with our talent.
Our core belief in diversity, complemented by the principles of kaizen, ensures we bring the best expert data talent to work transparently, collaboratively, and with the flexibility to ensure client success.
Visit http://www.kaygen.com/ for a solutions overview.
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