Clinical Trials Associate - Romanian Speaker

The associate is responsible for coordinating regulatory and ethics submissions, supporting site training and documentation, and maintaining inspection readiness through accurate and complete trial records, including the Trial Master File (TMF). Additional responsibilities may be assigned based on local regulatory requirements, geographic needs, or regional operational differences.

Key Responsibilities

• Support investigator site start-up activities, including collection, review, and submission of regulatory documentation

• Coordinate customization and negotiation of informed consent documents

• Act as the primary liaison with Ethics Review Boards (ERBs) and Competent Authorities (CAs), where applicable

• Track and ensure site compliance with required training and regulatory obligations

• Drive site activation and maintenance timelines in alignment with study and organizational priorities

• Maintain regular communication with investigator sites throughout start-up, maintenance, and close-out phases

• Proactively identify, escalate, and resolve site-related issues

• Ensure country-specific regulatory and data privacy requirements are reflected in submissions, documents, and systems

• Utilize prior site and ethics committee experience to streamline start-up and regulatory processes

• Maintain accurate and up-to-date information in internal tracking systems related to trial and site performance

• Ensure compliance with procurement, legal, and financial processes

• Populate and maintain Trial Master Files and document repositories to support audit and inspection readiness

• Share feedback and lessons learned to support continuous process improvement

• Manage competing priorities and adapt to changing study or portfolio demands

Qualification Requirements

• Bachelor's degree, preferably in a scientific, life sciences, or health-related field

• General understanding of the clinical development process and the importance of efficient site activation

• Working knowledge of project management principles and processes

• Experience working in a regulated, compliance-driven environment

• Strong communication, negotiation, and problem-solving skills

• Excellent organizational skills with the ability to work independently

• Native Romanian speaker with fluency in English is required

Preferred Experience

• Two or more years of experience in clinical research, clinical operations, or a related field