OBIO Job Board and Talent Network™️

Connect with highly skilled talent in the health science industry.

Senior Clinical Trial Associate

Fusion Pharmaceuticals

Fusion Pharmaceuticals

Operations
United States · Boston, MA, USA
Posted on Wednesday, June 26, 2024

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.

Summary:

The Senior 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:

  • 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 study logistics in support of clinical trials.
  • With CTM oversight, assists with 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.
  • With CTM oversight, reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
  • Responsible for and/or aids CRO in set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files in accordance with eTMF plan.
  • Coordinates TMF transfer with CROs.
  • Responsible for maintenance of internal SharePoint and Box files.
  • Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues and escalates to CTM as needed.
  • Assists CTM in review and approval of informed consent templates.
  • Responsible for agendas, meeting minutes, and tracking action items for clinical study team meetings.
  • Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CTM 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
  • Proficient in Microsoft programs such as Word, Excel, PowerPoint
  • Proactively seeks out and recommends process improvements

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.