Responsibilities
Job Description:
- 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
- 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
Minimum Qualifications
- 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
Preferred Qualifications
- 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 in Human trials
- Experience with regulatory affairs, including IND/CTA submissions
Competencies
- 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.
CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.
Clinical Trial Associate: Base pay range of $85,000 to $95,000+ bonus, equity and benefits.
The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
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.
To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy
