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Cypress HCM · 1 month ago

Clinical Trial Assistant

Tustin, CA

Full-time

Onsite

Mid Level

$25/hr - $32/hr

3+ years exp

Cypress HCM is a growing company that focuses on precise, early detection of emerging diseases. The Clinical Trial Assistant (CTA) will support the planning, execution, and documentation of clinical studies in compliance with applicable regulations and internal procedures.

Human ResourcesInformation TechnologyStaffing Agency

Growth Opportunities

Hiring Manager

Emily Gray (List)

Responsibilities

Support study start-up, maintenance, and close-out activities across multiple clinical trials

Partner with CROs, clinical sites, and vendors to drive on-time achievement of critical study milestones

Oversee clinical supply chain management, including inventory tracking, shipment coordination, and site correspondence

Develop and review essential study documentation, including protocols, informed consent forms, case report forms, and monitoring plans

Facilitate data collection processes and drive timely resolution of data queries

Contribute to internal and external meetings by documenting key decisions, action items, and ensuring timely follow-through

Prepare regulatory submissions, ethics committee applications, and study start-up packages to support trial initiation

Qualification

Clinical trial managementIVD regulatory knowledgeTrial Master File systemsLife sciences degreeClinical trial processesExcel proficiencyWord proficiencyPowerPoint proficiencyProblem-solvingOrganizational skillsCommunication skills

Required

Bachelor's degree in life sciences, healthcare or similar field

3–5 years of experience as a CTA in healthcare, biotech, diagnostics, or medical device industry

Working knowledge of IVD clinical trial design and applicable regulatory requirements, including IVDR, ISO 14155, and Good Clinical Practice guidelines

Proficiency with Trial Master File systems and clinical trial management platforms for documentation and study tracking

Comprehensive understanding of clinical trial processes, documentation standards, and operational workflows

Able to work independently and collaboratively

Detail-oriented with a proactive approach to problem-solving

Strong organizational and communication skills

Proficient Excel, Word and PowerPoint skills