Clinical Trial Associate, Clinical Operations - Remote

Overview

Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

In Short

• The Clinical Trial Associate (CTA) is responsible for the successful execution of clinical trials.
• Support clinical study teams and manage internal and external eTMF.
• Prepare for audits and inspections.
• Coordinate logistics for meetings and capture meeting minutes.
• Maintain updates on Clinical Trial Governance.
• Lead biospecimen inventory and tracking.
• Assist with site contracts and budget tracking.
• Collaborate with the Clinical Trial Manager on reviewing Trial Master Data.
• Contribute to Study Plans.
• Support the filing of appendices for the Clinical Study Report.

Requirements

• B.A./B.S. in life sciences or equivalent.
• A minimum of 2 years of clinical research experience.
• Working knowledge of FDA/ICH guidelines and Good Clinical Practices.
• Experience utilizing CTMS, EDC, TMS, and related software preferred.
• Proficient in Microsoft Office products.
• Attention to detail and excellent organizational skills.
• Ability to manage changing priorities.
• Excellent communication and interpersonal skills.
• Motivated to work in a fast-paced environment.
• Ability to efficiently perform multiple tasks.

Benefits

• Opportunity to work in a fast-paced, dynamic environment.
• Market competitive compensation and benefits package.
• Unlimited PTO.
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings.