Clinical Trial Associate (One-Year Contract) jobs in United States
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CRISPR Therapeutics · 4 days ago

Clinical Trial Associate (One-Year Contract)

CRISPR Therapeutics is a leading company in the field of gene editing, focused on developing transformative medicines for various diseases. The Clinical Trial Associate (CTA) will assist in the execution of clinical trials by coordinating documents and supporting clinical operations to ensure compliance with regulations and internal SOPs. This role is critical in maintaining effective communication and organization within the clinical trial team, contributing to the advancement of innovative therapies.

BiopharmaBiotechnologyGeneticsMedical
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H1B Sponsor Likelynote

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

Qualification

Clinical operations experienceClinical Practice (GCP)ETMF experienceDrug development knowledgeMS Excel proficiencyEffective communicationOrganizational skillsInterpersonal skillsAttention to detailTime management

Required

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

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

Company

CRISPR Therapeutics

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CRISPR Therapeutics is focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

H1B Sponsorship

CRISPR Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (18)
2024 (25)
2023 (16)
2022 (18)
2021 (13)
2020 (16)

Funding

Current Stage
Public Company
Total Funding
$407M
Key Investors
EcoR1 CapitalBill & Melinda Gates FoundationVersant Ventures
2024-02-13Post Ipo Equity· $280M
2020-12-14Grant
2016-10-19IPO

Leadership Team

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Raju Prasad
Chief Financial Officer
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Naimish Patel
Chief Medical Officer
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Company data provided by crunchbase