Clinical Trial Associate

Job ID
2017-1106
Category
Clinical Operations
US-MA-Cambridge

Company Summary

Jounce Therapeutics, Inc. (JNCE) is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in a Phase 1/2 trial.

 

The successful candidate for this CTA position will assist with daily clinical trial execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with FDA regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.

Role / Responsibilities

  • 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.
  • Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals
  • Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
  • 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

Qualifications

  • BS/BA degree or equivalent and at least 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 is required
  • Experience with eTMF; ability to directly apply essential document knowledge to file documents
  • Strong communication, organizational and interpersonal/team skills
  • Proficient in MS Excel, Word and PowerPoint.  Knowledge of MS project 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 customer service orientation
  • Strong attention to quality/detail

To apply, please visit our website at https://careers-jouncetx.icims.com 

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