Clinical Trials Associate
At Viridian, we work with urgency on behalf of patients—fostering unity across our team, the industry, and the broader community. We are committed to applying proven science and engineering to improve the lives of people living with serious and rare diseases, and we move closer to that goal every day.
The Clinical Trial Associate (CTA) is a critical member of the Clinical Operations team, supporting clinical research studies from start-up through close-out. This role is responsible for managing essential documentation, coordinating trial activities, and ensuring compliance with company SOPs, ICH-GCP guidelines, and applicable Code of Federal Regulations requirements.
This position is based at our headquarters in Waltham, Massachusetts. Office-based employees are required to work onsite three (3) days per week.
Key Responsibilities
• Maintain and oversee the Trial Master File (TMF), including distribution, collection, tracking, review, and archiving of essential documents throughout the study lifecycle
• Ensure completeness and quality of TMF documentation through regular audits and file reviews
• Manage filing indexes, correspondence logs, training documentation, and other study-related records
• Establish, organize, and maintain clinical study records within Viridian’s electronic systems (GxP Egnyte and eTMF)
• Support site communications, including feasibility activities, site identification, and ongoing updates
• Coordinate distribution of clinical trial materials and documentation; manage site equipment inventory and returns
• Provide study materials and supplies to investigational sites and CRO partners as needed
• Develop and maintain study trackers and status reports to support clinical study progress
• Coordinate clinical team meetings, including teleconferences; assist with agendas, meeting minutes, and action item tracking
• Complete all required company and study-specific training (SOPs, policies, study documents) by assigned deadlines
Apply tot his job
Apply To this Job
The Clinical Trial Associate (CTA) is a critical member of the Clinical Operations team, supporting clinical research studies from start-up through close-out. This role is responsible for managing essential documentation, coordinating trial activities, and ensuring compliance with company SOPs, ICH-GCP guidelines, and applicable Code of Federal Regulations requirements.
This position is based at our headquarters in Waltham, Massachusetts. Office-based employees are required to work onsite three (3) days per week.
Key Responsibilities
• Maintain and oversee the Trial Master File (TMF), including distribution, collection, tracking, review, and archiving of essential documents throughout the study lifecycle
• Ensure completeness and quality of TMF documentation through regular audits and file reviews
• Manage filing indexes, correspondence logs, training documentation, and other study-related records
• Establish, organize, and maintain clinical study records within Viridian’s electronic systems (GxP Egnyte and eTMF)
• Support site communications, including feasibility activities, site identification, and ongoing updates
• Coordinate distribution of clinical trial materials and documentation; manage site equipment inventory and returns
• Provide study materials and supplies to investigational sites and CRO partners as needed
• Develop and maintain study trackers and status reports to support clinical study progress
• Coordinate clinical team meetings, including teleconferences; assist with agendas, meeting minutes, and action item tracking
• Complete all required company and study-specific training (SOPs, policies, study documents) by assigned deadlines
Apply tot his job
Apply To this Job