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Senior/Clinical Trial Associate

Cambridge, MA

About Theseus

Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): “pan-variant” targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn.

Role Description

The Clinical Trial Associate (CTA) at Theseus Pharmaceuticals, Inc. is responsible for supporting and coordinating the logistical aspects of clinical trials under the direction of the Clinical Trial Manager.  They provide support during clinical trial planning and execution of timelines, budgets and study activities.  The CTA participates in a variety of clinical activities to facilitate and support the conduct of clinical research at Theseus Pharmaceuticals in accordance with FDA, EMA, GCP, and ICH guidelines.  This role may be responsible for collaborative oversight of cross-functional study team activities, as well as communication with external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other external partners).

Key Responsibilities

  • Works side-by-side with Clinical Trial Manager(s) to assist in clinical trial management tasks and coordination and tracking of study logistics, as delegated
  • Liaises with CROs and other clinical vendors as directed to ensure deliverables are met.  Provides information and resolution for specific study requests and issues and escalates to CTM as needed.
  • Supports management of team calendar; prepares and distributes agenda and minutes for project team meetings; Maintains action item and decision logs
  • Assists in the development of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study related documents
  • Assists CTM in review and approval of country informed consent templates; reviews site specific ICFs for start up and amendments
  • With CTM oversight, assists with tracking study budgets, including invoice review, PO management/reconciliation, and month-end activities in support of the CTM and Finance; Works closely with CTM and legal to review and approve clinical trial agreements and site specific study budgets.
  • Supports the clinical team with planning and preparation of investigator meetings and conference attendance
  • Assists in the oversight of clinical supply shipments, study equipment, and study-specific laboratory samples
  • Provides oversight of activities related to safety reporting compliance to Investigative Sites
  • Reviews and maintains study-level training documentation
  • Maintains study trackers, study contact lists, and other operational tools for the assigned clinical trials.
  • Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review of study-specific essential regulatory document packets prior to site activations
  • Posts, updates, and maintains information on gov registry(ies) and other registries as appropriate
  • Manages submission of documents to and maintenance of the Trial Master File (TMF); reviews TMF documents as part of quality control; acts as primary liaison with the CRO to collect trial documents and coordinate review of the TMF to ensure inspection-readiness at all times; coordinates transfer of TMF from CROs and manages archiving of the TMF
  • Manages insurance certificate requirements
  • Maintains internal document repositories (e.g. Sharepoint)
  • May assist the Clinical Trial Manager with site management activities, including review of monitoring reports and tracking of site visits.
  • May assist the Clinical Trial Manager with vendor management and oversight responsibilities
  • May assist the Clinical Trial Manager with preparation for FDA and other regulatory body audits/inspections, as required.
  • Assists with identifying and implementing best practices and continuous improvement plans within the company
  • May participate in SOP, work instruction, and/or template development and review
  • Performs administrative functions and additional duties as assigned and appropriate

Qualifications

  • 2+ years of clinical research experience in a clinical research organization or sponsor setting (Biotech industry experience preferred)
  • Ability to handle a high volume of highly complex tasks within a given timeline; excellence in task management
  • Excellent attention to detail and effective organization skills with a passion for delivering quality results
  • Strong written and verbal communication skills with ability to build relationships internally and externally
  • Working knowledge of GCP, CFR, and ICH Guidelines
  • Positive, friendly and can-do attitude; self-motivated and able to work autonomously as well as a member of a collaborative team
  • Ability to “roll up sleeves” in a start-up environment
  • Demonstration of effective problem solving; ability to independently find solutions to challenges
  • Proficient in Microsoft programs such as Word, Excel, PowerPoint
  • Proactively seeks out and recommends process improvements; intellectual curiosity
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