Clinical Trial Associate / Senior Clinical Trial Associate

Boston, MA, United States

Company Overview

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 Bayer and 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.

Position Summary

Working closely with the Associate Director, Clinical Operations, the Clinical Trial Associate/ Sr. Clinical Trial Associate (CTA) position will assist with daily clinical trial execution activities including enrollment management, vendor oversight, and 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 CTA/ Sr. CTA will support the day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail, is capable of working independently, and has the ability both to prioritize and handle multiple tasks effectively in a rapid environment.

Responsibilities

Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget

Identify issues and implement solutions to ensure timelines are maintained

Organize/maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out

Oversee vendors and actively participate in all UATs for vendor systems, including IRT, EDC, Central Labs, etc

Responsible for internal meeting agendas/minutes as applicable, and recording and disseminating decisions and actions

Responsible for updating, maintaining and quality control of the eTMF, SharePoint site, and shared drive

Coordinate training for the assigned clinical study

Responsible for study laboratory sample tracking and vendor management support

Set up, manage, and track new vendors and purchase orders in financial system

Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision

Work collaboratively with supply chain to ensure seamless delivery of drug product to clinical sites

Support Clinical Operations team with specific projects

Effectively communicate with study team members and work closely to address challenges

Minimum Qualifications Clinical Trail Associate: BS/BA degree or equivalent and at least two years experience in clinical operations in Sponsor company

Senior Clinical Trial Associate: BS/BA degree or equivalent and at least three 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 CRO and/or 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

Knowledge of cellular therapies

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.

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

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