About this opportunity
Crispr Therapeutics AG lists this Clinical Trial Associate opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
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 Clinical Trial Manager, 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 ideal candidate will have keen attention to detail and has the ability both to prioritize and independently handle multiple tasks effectively. This incredible opportunity will put the right candidate at the forefront of medicine, working on ground breaking 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.
Responsibilities
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
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 Greenlight Documentation Packages
Support Clinical Operations team in new process development or optimization
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 research
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.
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
Experience inside a Sponsor or CRO 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
Core 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.
Work Environment
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.
Compensation & Benefits
Base pay range of $85,000 to $95,000+ bonus, equity and benefits
EEO Statement
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.
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.
Additional Information
To view our Privacy Statement, please click the following link:
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies 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, and business offices in London, United Kingdom.
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Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.