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CRISPR Therapeutics
Boston, MA, United States
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular an
Job Source: CRISPR TherapeuticsScorpion Therapeutics
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and da
Job Source: Scorpion TherapeuticsScorpion Therapeutics
Boston, MA, United States
Job Summary: We are seeking a highly motivated and detail-oriented individual to join our team as a Clinical Trial Associate/Sr. Clinical Trial Associate. As a Clinical Trial Associate at Scorpion Therapeutics, you will play a vital role in the planning, coordination, and execution of our early phase clinical trials, ensuring compliance with regul
Job Source: Scorpion TherapeuticsScorpion Therapeutics
Boston, MA, United States
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and da
Job Source: Scorpion TherapeuticsCRISPR Therapeutics
Boston, MA, United States
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular an
Job Source: CRISPR TherapeuticsBeacon Hill
Waltham, MA, United States
100% Remote - Clinical Trial Associate Contract Onsite - 3-4 days Experience required: 4+ years as CTA. Sponsor / Pharma experience Experience with late stage study close out. ADDITIONAL DETAILS: Majority of studies are late phase - iii, iv, registry studies, etc. Therapeutic area is Rare Disease. Focus on close out activities and TMF compliance.
Job Source: Beacon HillAcrivon Therapeutics Inc.
Watertown, MA, United States
Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon's proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The AP3 platfor
Job Source: Acrivon Therapeutics Inc.Monte Rosa Therapeutics, Inc
Boston, MA, United States
Overview: We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The CTA position is focused on providing support associated with the plan
Job Source: Monte Rosa Therapeutics, IncWatertown, MA, United States
Title: CTA
Location: Waltham, MA Hybrid (3 days in the office a week is a must have)
Pay Rate: Open W2
Position Overview : The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Managers in day-to-day activities including engaging vendors, starting up and managing clinical trials. 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.
Key Responsibilities:
Organize/maintain tracking systems and set up tools to support the conduct of a clinical study from start-up to close-out
Assist with the development and review of clinical documents including protocols, ICFs and clinical study plans
Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
Facilitate vendor engagement from RFP distribution through to final contracting and PO set up
Setup and organize Sharepoint and central study files
Coordinate training for the assigned clinical study
Manage study laboratory sample tracking and vendor management support
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 one year experience in clinical operations in Sponsor company with 1+ years strongly preferred
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
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
Experience working on dermatology
Email Alert for Clinical Trial Associate jobs in Watertown, MA, United States
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