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 Trial Manager and SVP of Development Operations with administrative activities. 

Key Responsibilities:

1. eTMF Management:
- Proactively review internal and/or external eTMF, perform spot checks, and address any inconsistencies.
- Prepare for audits and inspections.
2. Meeting and Communication Management:
- Coordinate logistics for internal and external meetings.
- Prepare meeting agendas and document meeting minutes.
- Provide updates on Clinical Trial Governance via clinicaltrails.gov.
3. Plans and Resource Management:
- Maintain staff and vendor lists.
- Collaborate with the Clinical Trial Manager (CTM) on reviewing Trial Master Data (TMD)
- Contribute to Trial Oversight and TMF Plans.
4. Other Core Activities:
- Take a lead role in clinical biospecimen inventory and tracking.
- Assist with site contracts, trial dashboard updates, and trial budget maintenance.
- Support the filing of appendices for the Clinical Study Report (CSR).
- Prepare for inspections.

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 $90,000 to $110,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.