Job Description

About the Role

We are seeking a detail-oriented and proactive Clinical Research Administrative Assistant to support our clinical study teams and ensure seamless operations and compliance across domestic and international studies. You’ll play a key role in document management, regulatory tracking, device shipment coordination, and communication support to ensure studies run smoothly and meet all applicable guidelines and regulatory standards.

Key Responsibilities

Prepare and manage regulatory/subject binders and ship to study sites
Assist in the setup and maintenance of study websites
Maintain and track essential study documents and correspondence in the Trial Master File
Track IRB/EC approvals, site regulatory submissions, and study enrollment updates
Support audit readiness and assist during internal/external audits
Coordinate and monitor clinical device demo shipments and special study supplies
Provide general support to project teams, including meeting scheduling, agenda preparation, and minutes documentation
Assist with the development of study site communications such as newsletters
Archive study records in compliance with records retention policy
May assist with site activation and closure activities as needed
Collaborate with in-house CRAs, project managers, and clinical teams to ensure smooth study execution
Maintain confidentiality and handle sensitive clinical information appropriately

Qualifications

Minimum 1 year of experience in clinical research, pharmaceuticals, medical devices, or relevant hospital/clinical setting
Proficient with Microsoft Office Suite (Word, Excel, Outlook); experience with document tracking systems a plus
Strong organizational skills with a high level of attention to detail
Excellent written and verbal communication skills
Able to work independently and collaboratively with global teams
Familiarity with Good Clinical Practices (GCP) and applicable regulatory standards
Ability to manage multiple tasks and meet deadlines in a fast-paced environment
Reliable with consistent attendance and punctuality

What We Offer

Competitive salary + overtime for hours beyond 40/week
Professional growth in a high-impact clinical environment
Supportive and collaborative work culture
Opportunity to contribute to meaningful healthcare innovations