Clinical Trial Associate

ResponsibilitiesJob Description:Help maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-outCollect trial information and disseminate it to the internal project team, the CRO, and other stakeholdersCoordinate study meetings, materials and agendas; recording and disseminating decisions and actionsResponsible for internal meeting agendas/minutes as applicableResponsible for updating, maintaining and quality control of the eTMF, SharePoint site and shared driveResponsible for study laboratory sample tracking and vendor management supportTrack new vendors and purchase orders in financial systemCoordinate version control of clinical documents, prioritize multiple tasks and/or projectsAssist in coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation PackagesSupport Clinical Operations team with specific projectsEffectively communicate with study team members and work closely to address challengesMinimum QualificationsBS/BA degree or equivalent and at least 1-3 years experience in clinical operations in Sponsor companyKnowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out proceduresKnowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal RegulationsExperience with eTMF; ability to directly apply essential document knowledge to file documentsEffective communication, organizational and interpersonal/team skillsProficient 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 timelinesParticipate in inter-departmental workgroups to create or enhance processesStrong attention to quality/detailGood organizational and time management skillsWillingness to work in a flexible environmentPreferred QualificationsAdditional Years of clinical operations experience inside a Sponsor companyExperience with global studies, using an outsourced CRO modelExperience in clinical drug development with knowledge of First in Human trialsExperience with regulatory affairs, including IND/CTA submissionsCompetenciesCollaborative – Openness, One TeamUndaunted – Fearless, Can-do attitudeResults 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