Clinical Trial Operations Coordinator

Crispr Therapeutics AG; Boston, Northern (MA, KY); Hybrid; USD 85,000 - 95,000; Full time

Job summary

CRISPR Therapeutics in Boston, MA seeks an experienced Clinical Trial Associate to support daily trial execution, document coordination, and eTMF quality control. You will collaborate with the Clinical Trial Manager and CROs to ensure regulatory compliance and timely deliverables.

The role requires 1–3+ years in clinical research, strong communication skills, and proficiency in MS Office. A flexible hybrid environment with on-site collaboration is offered.

Qualifications

• BS/BA degree or equivalent and at least 1-3+ years experience in clinical research.
• Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures.
• Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations.
• Experience with eTMF; ability to directly apply essential document knowledge to file documents.
• Effective communication, organizational and interpersonal/team skills.
• Proficient in MS Excel, Word and PowerPoint.
• Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
• Participate in inter-departmental workgroups to create or enhance processes.
• Strong attention to quality/detail
• Good organizational and time management skills
• Willingness to work in a flexible environment

Responsibilities

• Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
• Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
• Coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
• Responsible for internal meeting agendas/minutes as applicable
• Responsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared drive
• Responsible for study laboratory sample tracking and vendor management support
• Coordinate version control of clinical documents, prioritize multiple tasks and/or projects
• Assist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Greenlight Documentation Packages
• Support Clinical Operations team in new process development or optimization
• Effectively communicate with study team members and work closely to address challenges

Skills

Clinical research

GCP knowledge

Project coordination

Communication

Time management

Education

BS/BA degree

Tools

eTMF

MS Excel

MS Word

PowerPoint

Job description

CRISPR Therapeutics in Boston, MA seeks an experienced Clinical Trial Associate to support daily trial execution, document coordination, and eTMF quality control. You will collaborate with the Clinical Trial Manager and CROs to ensure regulatory compliance and timely deliverables.

The role requires 1–3+ years in clinical research, strong communication skills, and proficiency in MS Office. A flexible hybrid environment with on-site collaboration is offered.