Clinical Trial Associate

Company Overview

Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Working closely with the Clinical Trial Manager, 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). The ideal candidate will have keen attention to detail and has the ability both to prioritize and independently handle multiple tasks effectively.

This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking trials with tremendous potential to impact patient's lives. You will join a team of incredibly dedicated professionals whose talent is matched by their commitment and passion for the work we are doing. A team that remains focused on what's important for the patient and also has an incredible track record of growth and development among them.

If you are looking to learn, work hard, and make a difference, we would like to speak with you.

• 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

• 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…