Clinical Trial Associate
Reporting to the Director of Clinical Operations.
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 CTA will support the Director of Clinical Operations and 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.
- Organize/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
- Schedule and 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
- Coordinate training for the assigned clinical study
- Responsible for study laboratory sample tracking and vendor management support
- Set up, manage, and track new vendors and purchase orders in financial system
- Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
- 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
- BS/BA degree or equivalent and at least one year experience in clinical operations in Sponsor company with 1+ years strongly preferred
- 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
- 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
- Knowledge of transplant, oncology or cellular therapies
- 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.
If interested and qualified, please include Requisition # 2019-418 in the subject line when emailing resume to: firstname.lastname@example.org.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.