Clinical Trial Associate - Clinical Operations

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 $75,000 to $97,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.