Position: Clinical Trial Associate
Company: Meditrial
- Location: New York, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: 2 days ago
- Offer language: English
Job description
Industry: Lifescience Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial USA Inc., 866 United Nations Plaza, NY 10017
Workplace: In Office
We are looking for a Clinical Trial Associate to join our growing CRO team and support clinical operations in compliance with international regulations and quality standards.
The Clinical Trial Associate provides operational and administrative support across all stages of clinical trial execution, working closely with Clinical Operations, Quality, and Project Teams. The ideal candidate is practical-minded, detail-oriented, and has a background in life sciences, quality systems, and clinical trial operations, preferably within the medical device field.
This role offers hands-on exposure to international clinical trials, mainly in the cardiovascular therapeutic area, and represents an excellent opportunity to grow within a structured, quality-driven clinical research environment.
Responsibilities
- Support the Clinical Quality Manager with administrative and documentation-related activities
- Assist clinical teams in the management of clinical trials, including use of EDC systems and CTMS, in accordance with internal SOPs
- Support the assessment and management of medical device clinical trials in compliance with applicable regulations
- Collect, review, draft, track, and maintain regulatory and investigator documentation for submissions to FDA and IRBs
- Provide administrative support during study start-up activities, including document collection, investigator communication, and internal progress tracking
- Manage SAE notifications
- Support the preparation and maintenance of reports, spreadsheets, presentations, and study documentation
- Establish, maintain, and update trial master files and internal records
Skillset & Qualifications
- Education: Bachelor’s degree, Master is a plus;
- Minimum 2 years experience in life science field in a coordinator capacity and Quality Management;
- Languages: proficiency in oral and written English (second language considered a plus);
- Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);
