Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
Coordinate study documents and training tools for coordination with clinical sites
Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
Coordinate study meetings, materials and agendas; record and disseminate decisions and actions
Responsible for internal meeting agendas/minutes as applicable
Responsible for updating, maintaining and quality control of the eTMF and other document repositories
Responsible for study laboratory sample tracking and vendor management support
Track new vendors and purchase orders in financial system
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 Documentation Packages
Support Clinical Operations team with specific projects
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 operations in Sponsor company
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. Knowledge of MS project and SharePoint preferred.
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
Additional Years of clinical operations experience inside a Sponsor company
Experience with global studies, using an outsourced CRO model
Experience in clinical drug development with knowledge of First i
Benefits
Flexible schedule
Additional Information
Job Description:
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
Position Summary
Working closely with the Associate Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract 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 CTA will support the Clinical Trial Managers (CTM) in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.
This incredible opportunity will put the right candidate at the forefront of medicine, working on groundbreaking 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.
Crisprtx · South Boston, MA