Clinical Trial Associate

Crispr Therapeutics AG; Boston, Northern (MA, KY); Hybrid; USD 85,000 - 95,000; Full time

Job summary

CRISPR Therapeutics in Boston, MA seeks an experienced Clinical Trial Associate to support daily trial execution, document coordination, and eTMF quality control. You will collaborate with the Clinical Trial Manager and CROs to ensure regulatory compliance and timely deliverables.

The role requires 1–3+ years in clinical research, strong communication skills, and proficiency in MS Office. A flexible hybrid environment with on-site collaboration is offered.

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

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

Skills

Clinical research

GCP knowledge

Project coordination

Communication

Time management

Education

BS/BA degree

Tools

eTMF

MS Excel

MS Word

PowerPoint

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: http://www.crisprtx.com/about-us/privacy-policy

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.