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, SharePoint 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 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 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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Gene-editing pioneer (Nasdaq: CRSP) using CRISPR/Cas9 to develop therapies for blood disorders, oncology, and in vivo gene editing; co-developer of Casgevy. Headquartered in Zug, Switzerland with US operations in Boston, MA.

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