Clinical Trial Associate, Clinical Operations
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. Role Summary: The Clinical Trial Associate (CTA) is a pivotal role responsible for the successful execution of clinical trials. The CTA is responsible for supporting clinical study teams, tracking clinical biospecimens, and managing internal and/or external (eTMF) to ensure inspection readiness at trial level as directed, by supporting the Clinical Operations team with administrative activities. Key Responsibilities:
- eTMF Management:
- Manage documents in the internal and/or external eTMF, review documents for completeness and accuracy, perform spot checks, and address any inconsistencies.
- Prepare for audits and inspections.
- Meeting and Communication Management:
- Coordinate logistics for internal and external meetings.
- Prepare meeting agendas and capture meeting minutes.
- Maintain updates on Clinical Trial Governance via clinicaltrails.gov.
- Plans and Resource Management:
- Maintain and update staff and vendor contact lists.
- Collaborate with the Clinical Trial Manager (CTM) on reviewing Trial Master Data (TMD)
- Contribute to Study Plans.
- Other Core Activities:
- Lead biospecimen inventory and tracking.
- Track and oversee start-up activities (site/country submissions, essential documents, and trackers).
- Assist with site contracts, trial dashboard updates, and budget tracking.
- Support the filing of appendices for the Clinical Study Report (CSR).
- Other duties as assigned
Ideal Candidate:
- B.A./B.S. in life sciences or equivalent
- A minimum of 2 years of clinical research experience, preferably within the pharmaceutical or biotech industry.
- Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices.
- Experience utilizing CTMS, EDC, TMS, and related software preferred.
- Proficient in Microsoft suite of products; Microsoft Word, Excel, PowerPoint, Outlook
- Attention to detail, and excellent organizational and prioritization skills.
- Motivated to work in a fast-paced, high-accountability environment.
- Ability to efficiently perform multiple tasks and manage changing priorities.
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
What We Offer:
- Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
The expected salary range offer for this role is $ 95,000 to $110,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/. Apply tot his job Apply To this Job