Clinical Trial Associate
TCR² Therapeutics Inc. is an immuno-oncology company developing novel cancer therapies that unleash the full signaling power of complete T cell receptors (TCR). TCR² has developed a unique proprietary TRuC™ platform which can reprogram the natural TCR complex to recognize specific antigens found on tumors where they elicit rapid killing of cancer cells. The company has demonstrated activity against both hematological and solid tumor targets in preclinical models and believes its TRuC™-reprogrammed T cells will serve as the engine for important therapies. TCR² was founded by MPM Capital and has scientific operations in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories around the world.
TCR² Therapeutics is building a clinical development team and is seeking talented and independent candidates to execute its clinical studies. The successful candidate will ensure TCR² Therapeutics’ clinical trial(s) are managed to the highest quality to ensure safety and effectiveness of TCR² Therapeutics’ products in adherence with regulations. The position is an excellent opportunity for career development as TCR² Therapeutics is in the midst of building out the infrastructure to support an innovative clinical pipeline and the candidate will have the opportunity to help shape the future of the organization.
Supports the clinical study teams in the execution and delivery of studies
Organizes, manages, and oversees the Trial Master File to maintain up-to-date regulatory documentation for all research sites
Responsible for study laboratory sample management, including tracking and vendor management support
Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
Responsible for quality control of the eTMF including maintenance and oversight
Coordinate and manage version control of clinical documents.
Assist in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
May act as a central contact for the study team for designated project communications, correspondence, and associated documentation
Performs administrative tasks to support team members with clinical trial execution, as needed
Assists the project team with the planning, preparation, and on-site support of investigators and other meetings
Assist with invoice and budget management.
Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections.
Prepare and maintain assigned program files.
BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of at least 1-2 years working on phase I-IV global clinical studies within a biopharmaceutical/biotech, CRO, or academic environment.
Biopharmaceutical/Biotech experience strongly preferred
Experience and understanding of global clinical trial operations; preference in the oncology and/or cell therapy space
Excellent knowledge of ICH/GCP and regulatory requirements
Thrives in a fast-paced and evolving environment
Must be proficient in MS Office Suite (Word, Excel, PowerPoint); preference for Microsoft Project and project management programs
Must be organized with attention to detail
Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
Strong customer service orientation
Strong attention to quality/detail
Office-based position in Cambridge, MA
Interested candidates should send their resume to firstname.lastname@example.org