Clinical Trial Associate (6-Month Contract) at CRISPR Therapeutics

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 Associate Clinical Trial Manager and Clinical Operations Team, the Clinical Trial Associate (CTA) contract 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 CTA will support the Clinical Trial Managers (CTM) in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and has the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment.

This incredible opportunity will put the right candidate at the forefront of medicine, working on groundbreaking 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
• Coordinate study documents and training tools for coordination with clinical sites
• Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
• Coordinate study meetings, materials and agendas; record and disseminate decisions and actions
• Responsible for internal meeting agendas/minutes as applicable
• Responsible for updating, maintaining and quality control of the eTMF and other document repositories
• Responsible for study laboratory sample tracking and vendor management support
• Track new vendors and purchase orders in financial system
• 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 Documentation Packages
• Support Clinical Operations team with specific projects
• 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 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 Share Point 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 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 transplant, oncology or 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.

Base pay range of $40.00 - $50.00 per hour.

The hourly rate provided is the reasonable estimate for this contract position. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.

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.

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