What are the responsibilities and job description for the Senior Clinical Trial Associate position at Intellia Therapeutics?
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 wantall ofour 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.
Senior Clinical Trial Associate
Job Summary
As Senior Clinical Trial Associate within the Development Operations organization, you will Assist in all phases of clinical trial activities (feasibility, start-up, maintenance and close-out) for assigned study. The Senior CTA may perform some management tasks with appropriate oversight.
Duties / Responsibilities
- Assist in all phases of clinical trial activities (feasibility, start-up, maintenance and close-out)
- Assist in development of internal and study related documents, as applicable (e.g. Informed Consent Forms, study reference manuals, study trackers, newsletters, etc)
- Participate in Study Team and Contract Research Organization (CRO) / Vendor meetings, as needed. May lead or serve as primary contact vendor activities as delegated by the Clinical Operations Lead / Study Manager
- Solicit meeting agenda topics, support agenda development, and distribute meeting agendas
- Draft meeting minutes and incorporate team comments after review
- Support for eTMF file management, as required for project and department requirements
- Primary reviewer of study regulatory documents
- Support the Clinical Operations and overarching Development organization on functional and cross functional projects
- Independently organizes, prepares reports, prioritizes and summarizes data, materials, and information for projects, per schedule and ad hoc requests
- Maintain, update and reconcile spreadsheets and study trackers to support various projects such as : (but not limited to) : financial trackers, review and finalization of study team minutes, trial master file (TMF) tracking, etc. May support creation of spreadsheets and trackers as directed by the Clinical Operations Lead / Study Manager
- Lead lab sample and EDC data tracking
- Support maintenance, update and / or reconciliation of project and timeline tracking software or spreadsheets and various summary reports to inform various project team stakeholders
- Support the creation of content for presentations and materials for functional project meetings as applicable
- Prepare study conduct tools as directed by the Study Lead
- May serve as a primary contact for external parties as directed by the Clinical Operations Lead / Study Manager
- Maintain confidentiality at all times
- Effectively communicate with study team members and work closely with Clinical Operations Lead / Study Manager
Supervisory Responsibilities
Requirements
BA / BS degree in related discipline preferred or associate degree and 3 years of professional experience
BA / BS degree with at least 1-2 years or associate degree with at least 3 years 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
Ability to sit or stand for multiple hours at a computer
Manual dexterity for keyboarding; may include repetitive movements
Covid-19 Vaccination Policy : All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.
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.
