Senior Clinical Trial Operations Team Assistant

 

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Who we are looking for:

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.  In this role 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, which may include vendor-related tasks such as scheduling and scribing for meetings, routing and tracking documents, monthly report status report data collation and other activities delegated by the Clinical Operations  Program Lead beginning at start-up through study close.

Key areas of responsibility:

• 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, i.e. 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 e.g. functional lines, vendors, systems etc. for status updates such as monthly reports and tracking of performance metrics, etc.
• 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 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 and tolerance to function within a fast pace and changing clinical trial landscape.
• Ability to multitask and manage multiple competing priorities, organize activities to ensure timelines, cost, and quality of deliverables. Win-win and growth mindset, attentive to detail and follow through working independently or within team setting.

 

The salary range for this position is $90,000 to $102,000. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.