Clinical Trial Assistant, Clinical Operations

Duties and Responsibilities

• Solicit Clinical Study Execution Team (CSET) meeting agenda topics, coordinate meetings, minutes, and logistical support.
• Support site management activities and provide status to CSET (e.g., tracking site documents, distributing study materials, site enrollment metrics, etc.).
• Liaise with internal teams and vendors for document collection and updates; act as primary CTA contact on studies.
• Filer study documents to the Trial Master File (TMF) and assist with TMF reviews. Maintain TMF and ensure document quality and completeness.
• May assist with protocol amendment documentation and version control.
• May assist with the development of basic department initiatives, process documents, and standard forms most used by CTAs.
• Support other clinical operations activities as appropriate.

Requirements and Qualifications

• BS, BA, or RN in a relevant scientific discipline.
• 1-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
• Basic understanding of FDA and EMA Regulations, ICH guidelines, GCP, and familiarity with standard clinical operation procedures (SOPs).
• Basic organization and communication skills.
• Proficient in MS Office (Word, Excel, Outlook) and project tracking tools.
• Demonstrate reliability, proactive communication, and quality in task execution.
• Apply knowledge of Clinical Operations in day-to-day assigned tasks.
• Thrive in a collaborative team setting and be driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Travel may be required (~10%).

Preferred Qualifications

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience preferred.