Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
- Assist in all phases of clinical trial activities (feasibility, start-up, maintenance and close-out) for assigned study.
- Assist in development of study related documents, as applicable (e.g., study reference manuals, study trackers, newsletters, etc)
- Participate in Study Team and Contract Research Organization (CRO) / Vendor meetings, as needed
- Solicit meeting agenda topics, support agenda development, and distribute meeting agendas
- Draft meeting minutes and incorporate team comments after review as directed by Study Lead
- Support for eTMF file management, as required for project and department requirements.
- Support the Clinical Operations and overarching Development organization on functional and cross functional projects as directed
- Organizes, prepares reports, prioritizes and summarizes data, materials, and information for projects, as directed per schedule and ad hoc requests
- Maintains, updates and reconciles spreadsheets and study trackers to support various projects such as: (but not limited to): review and finalization of study team minutes, trial master file (TMF) tracking, laboratory sample tracking, study start-up and other tracking requirements as related to study oversight, etc.
- Supports lab sample and EDC data tracking
- Support the preparation of study conduct tools as directed by the Study Lead
- Identification of potential deliverable or timeline challenges or bottlenecks at the assignment level; presents suggested prioritization or options
- Maintains confidentiality at all times
- Effectively communicate with study team members and work closely with Clinical Operations Lead/Study Manager
- BA/BS degree preferred or associate degree and 2 years of professional experience working in a clinical research environment (clinical site, CRO or biotech/pharma company) or demonstration of equivalent capability in a Clinical Operations role
- Basic knowledge of FDA regulations, ICH guidelines and Good Clinical Practice (GCP)
- High level of energy, passion for job, creative problem solver, proactive and highly productive
- Willingness to collect and summarize data and information from a variety of resources and stakeholder team members / departments
- Must have strong computer skills working with Microsoft office programs (Word, Excel, PowerPoint, Outlook and Microsoft Project)
- Outstanding organizational skills
- Team player with excellent attitude and excitement to cultivate strong cross functional relationships
- Excellent written and oral communication skills (timely, clear)
- Strong interpersonal skills that exemplify the Intellia core values
Meet your future team:
Reporting to the Sr. Manager/Associate Director/Director, Clinical Operations, the successful candidate will be responsible for supporting the organization to develop and implement clinical trials across the portfolio. Under the guidance of the clinical team responsibilities will include (but not limited to): coordination of various studies tracking and management of daily operational and administrative projects on the project team and activities for multiple areas supporting the Clinical Operations organization and the overarching Development organization, as applicable. This will include activities related to infrastructure, administrative and clinical programs / studies.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.