Senior Clinical Trial Operations Team Assistant

Role Summary

The Senior Clinical Operations Team Assistant (COTA) is an essential role within the Vor Bio study teams, providing day-to-day Clinical Operations Leader(s) support for one or more study teams. The Senior COTA supports clinical study team activities to ensure compliance with timelines, ICH/GCP, and company policies, procedures, and SOPs. The role enables efficient execution of clinical trials and will be responsible for performing a variety of specific study and operational tasks, including vendor-related tasks such as scheduling and scribing for meetings, routing and tracking documents, monthly status report data collation, and other activities delegated by the Clinical Operations Program Lead from start-up through study close.

Responsibilities

• Work proactively and independently to prioritize, perform and/or coordinate assigned activities, collaborating with cross-functional team members and key stakeholders to support successful delivery within established parameters set by the study team and compliance with SOP and quality standards to include but not limited to:
• Provide logistical/operational support for study(ies) and department meetings (scheduling/planning, agenda, distribution of minutes or equivalent, etc.).
• Management and oversight of Study Team shared repositories and communication platforms.
• Initiate and coordinate the completion of key activities, e.g. study level documents, forms and data entry into various clinical systems.
• Tracking, oversight of key activities, completion of forms, data entry into applicable systems, and collating study level information from multiple sources for status updates such as monthly reports and tracking of performance metrics.
• Support tracking and management of clinical trial data, clinical trial budget spend and vendor invoices.
• Assist with collection, review, QC and filing of essential documents, ensuring TMF completeness.
• Support Study Team and Quality Team with Inspection Readiness activities.
• Act as Subject Matter Expert or Technical Resource for key clinical trial processes, systems, and tasks.
• Support clinical operations with on-boarding for new hires, organization chart updates.
• Identify, recommend, and participate in special projects (workstreams, initiatives) for continuous improvements, best practice and operational efficiencies.

Qualifications

• BA/BS within life sciences or equivalent with at least 2+ years of relevant clinical trial or clinical research experience within CRO, biotech, pharma, or academic research facility.
• Study coordinator or CRA experience a plus.
• Strong knowledge of drug development SOPs, ICH/GCP requirements, clinical trials, medical terminology.
• Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel, TEAMS).
• Experienced with clinical trial applications, e.g., IRT, CTMS.
• Strong critical thinking and problem-solving capabilities able to make sound decisions within scope of role, engage and gather input from relevant stakeholders as appropriate.
• Adept communicator both written and verbal with ability to function in a fast-paced and changing clinical trial landscape.
• Ability to multitask and manage multiple competing priorities, organize activities to ensure timelines, cost, and quality of deliverables. Willingness to adopt a win-win and growth mindset, attentive to detail and follow through working independently or within a team.

Skills

• Logistical and operational coordination for study meetings and documentation
• Documentation control and TMF completeness
• Vendor management and budget tracking
• Cross-functional collaboration and communication
• Data entry and reporting in clinical systems

Education

• BA/BS in life sciences or equivalent