Clinical Trial Assistant
Harpoon Therapeutics is a clinical-stage immuno-oncology company focused on the discovery and development of novel, proprietary bispecific T cell engaging biologic drug candidates for the treatment of various cancers. Harpoon’s first product, HPN424, is in clinical development for prostate cancer, and the second product HPN536 is in clinical testing for mesothelin over-expressing tumors, such as lung, pancreatic and ovarian cancers . Harpoon currently has two additional products in development and intends to introduce these into clinical development by the end of 2020. Harpoon is led by an experienced management team and has raised more than $200 million from leading life science investors. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and clinical research.
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.
- Maintain and/or accelerate timelines for achieving clinical operational milestones
- File, track and maintain study activity
- Manage and ensure the paper and electronic Trial Master File (eTMF) meets FDA/ICH/GCP requirements
- Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs and CDAs) with study sites
- Participate in site start-up, interim and close-out activities, etc.
- Review regulatory packets for completeness and accuracy
- Participate in the design of study manuals, etc.
- Assist clinical teams with study supplies management
- Prepare and distribute Investigator Site Files (ISFs)
- Track departmental payments and vendor invoices
- Conduct study tracking activities (sites status, enrollment status, reconciliation activities, filing & archiving)
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Assist with meeting coordination: scheduling meetings, meeting agendas, meeting minutes, meeting materials (creating PowerPoint Presentations as directed by senior team members), and coordination of travel arrangements, off-site meeting rooms, etc.)
- Support quality review of electronic Case Report Forms (eCRFs)
- 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
- 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
- Knowledge and proficiency with Word, Excel, Power Point
- Ability to work collaboratively in a dynamic, fast-paced, timeline-based environment