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
Essential Skills Strong diagnostic acumen across imaging modalities. Exceptional written, verbal, and consultative communication. Ability to thrive in a collaborative, fast-paced clinical setting. Proficiency in PACS, RIS, and EHR systems.
Education
Clinical Study