Clinical Trial Associate

Job Description: 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, Share Point site and shared drive
• 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

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. Certain lab based and manufacturing positions are located fully on-site.

Clinical Trial Associate: Base pay range of $85,000 to $95,000+ bonus, equity and benefits.

The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role. 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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