Silverback Therapeutics, a Seattle-based biotechnology company, is seeking a highly motivated Senior Clinical Trial Associate to join our growing Clinical Development Department. The Senior Clinical Trial Associate (CTA) plays an integral role in the coordination of clinical trials by providing clinical operations support and in-house assistance to Clinical Operations staff.
- Supports the Clinical Operations team in study execution and may act as the central contact for project communication and documentation.
- Attends the study team meetings, takes, and distributes meeting minutes.
- Maintains and generates appropriate study tracking sheets (e.g., patient enrollment and IRB approvals).
- Ensures Inspection Readiness by managing the set-up, maintenance, and quality control of the Trial Master Files and supports oversight of the CRO’s management of Trial Master Files.
- Manages the Clinical Operational internal document filing system and documents.
- Assists in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages and IP release.
- May train other CTA staff and act as lead for work performed by CTA staff.
- Performs other responsibilities as assigned.
- Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
- Minimum of 4 years of experience working on clinical studies in pharmaceutical, biotech, or CRO setting. Prior CTA experience required.
- Experience with essential documentation for Trial Master Files.
- Knowledge of drug development, clinical operation processes and procedures according to FDA GCP/ICH regulatory guidelines.
- Thorough knowledge of medical terminology.
- Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
- Able to recognize need(s), find solutions and take initiative to address in pro-active manner.
- Excellent interpersonal and professional skills and ability to work collaboratively across functional teams.
- Strong organizational and time management skills.
- Excellent communication skills, both oral and written.
Silverback Therapeutics, Inc. is a clinical-stage biopharmaceutical company leveraging our proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases. Our platform enables us to strategically pair linker-payloads that modulate key disease-modifying pathways with monoclonal antibodies directed to specific disease sites. Initially, we are creating a new class of targeted immuno-oncology agents that direct a myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. We are located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to firstname.lastname@example.org. We are an equal opportunity employer.