Clinical Trial Assistant

Location
South San Francisco, CA
Posted
Jan 06, 2021
Required Education
Bachelors Degree
Position Type
Full time

Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.

We are seeking a highly motivated CTA to be responsible for the coordination of activities (primarily administrative tasks) associated with Clinical Trial startup and maintenance under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.       

        

Key Responsibilities

  • Manage and maintains the electronic Trial Master File (eTMF) per FDA/ICH/GCP requirements
  • Review and track study related documents
  • Review regulatory packets for completeness and accuracy
  • Participates to submission of protocol, amendments, inform consent forms and other documents to central IRBs
  • Assist clinical teams with study supplies management
  • Track and manage inventories of study related supplies
  • Conduct study tracking activities (sites status, enrollment status, reconciliation activities, filing & archiving)
  • Support internal and external study meetings (assists in preparing for Investigator and project team meetings, create meeting agenda/minutes templates, and takes and distributes meeting minutes)
  • Ability to show initiative and work independently when needed
  • Maintain portal for sites with study documents and contacts
  • Prepare and distribute Investigator Site Files (ISFs)
  • Perform other duties as requested

Skills and Qualifications

  • Bachelor’s Degree.A Bachelor’s Degree in biology-related field or equivalent healthcare or laboratory-related work experience is strongly preferred
  • At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred
  • Sound computer skills (proficient in the use of Excel, Word, Powerpoint; some experience with Electronic Data Capture [EDC] systems; an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences)
  • Competent in an electronic environment and with the handling of documentation in such environments
  • Commitment to excellence and high standards
  • Flexibility and a proactive orientation
  • Excellent organizational skills along with strong attention to detail
  • Excellent verbal and written communication, strong organizational and interpersonal skills
  • Ability to work collaboratively in a dynamic, fast-paced, timeline-based environment