Fusion Pharmaceuticals
  • Boston, MA, USA
  • Full Time

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Using its proprietary Fast-Clear Linker technology platform, Fusion attaches medical isotopes to targeting molecules creating novel, next-generation cancer treatments. In preclinical studies, the Company has shown the ability to precisely target and effectively kill solid tumor cells while minimizing the impact to healthy tissue. Fusion's lead program, FPI-1434, is currently in a Phase 1 trial. The Company completed an oversubscribed $125M Series B financing that will be used to advance FPI-1434 and initiate preclinical and clinical development on multiple new agents.  Fusion is supported by a strong syndicate of investors and has ambitious goals to expand its pipeline.

The Clinical Trial Associate is responsible for supporting the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials. This position is located in Boston, MA.

 

Responsibilities and job tasks will include:

  • Clinical study team member working closely with the Clinical Trial Manager (CTM) and Head of Clinical Operations and is responsible for coordination and tracking of logistics in support of clinical trials.
  • Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals 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.
  • Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
  • Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
  • Responsible for set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files.  Coordinates TMF transfer with CROs.
  • Responsible for maintenance of SharePoint.
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
  • Assists CTM in review of study plans.
  • Assists CTM in review and approval of informed consent templates.
  • Responsible for agendas and meeting minutes for clinical study team meetings.
  • Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CPM and external meeting planners.
  • Responsible for set-up and management of ClinicalTrials.gov.

 

Qualifications

  • BA/BS (preferably in industry or healthcare of science field).
  • Ability to handle a high volume of highly complex tasks within a given timeline.
  • Excellent interpersonal and negotiation skills
  • Strong verbal and written communication and presentation skills
  • Proactively seeks out and recommends process improvements
Fusion Pharmaceuticals
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