Clinical Trial Associate

About the role

The Clinical Trial Associate (CTA) position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and CRISPR Therapeutics standard operating procedures (SOPs).

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
• Cover 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
• Cover coordinate version control of clinical documents, prioritize multiple tasks and/or projects
• Aid 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

Requirements

• 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

Qualifications

• Experience inside a Sponsor or CRO company
• Experience with global studies, using an outsourced CRO model
• Experience in clinical drug development with knowledge of First in Human trials
• Experience with regulatory affairs, including IND/CTA submissions

Skills

• Collaborative – Openness, One Team
• Undaunted – Fearless, Can-do attitude
• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit – Proactive. Ownership mindset

Benefits

Base pay range of $85,000 to $95,000+ bonus, equity and benefits

Pay

$85,000 to $95,000+ bonus, equity and benefits

Schedule

Flexible work schedule with at least three days on-site