Clinical Trial Assistant (Remote & Full-Time)
Clinical Trial Assistant (Remote & Full-Time) Clinical Trial Assistant (Remote & Full-Time) Get AI-powered advice on this job and more exclusive features. Granata Bio is a biopharma company working to shape the future of reproductive health by reimagining what’s possible to help build families. Founded in 2018, we are dedicated to developing and accelerating fertility treatments that expand therapeutic choices and improve access and affordability. Our people are passion-driven reproductive health experts who understand that innovation never stands still, and neither do we. Each day, we roll up our sleeves and put in the work to move one step closer to unlocking new possibilities for fertility patients and their care teams.Our ideal teammates show up in big ways by embracing productivity, authenticity, and the courage to drive innovation. Position Summary: We are looking for an experienced and resourceful Clinical Trial Assistant (CTA) to support our Clinical Operations team in a fast-paced, agile biopharma environment. As part of a small, highly collaborative team, the CTA will play a critical role in coordinating clinical trial activities, managing documentation, and liaising with a broad network of external vendors and partners. This position requires a hands-on approach, strong organizational skills, and the ability to work independently while supporting multiple projects. Key Responsibilities: Trial Support & Documentation
- Maintain and manage the Trial Master File (TMF), ensuring completeness, accuracy, and inspection readiness across all trial phases.
- Perform quality control (QC) checks and assist with TMF reconciliation and archiving.
- Track and manage essential documents including site contracts, regulatory submissions, informed consent forms, and investigator site files.
- Act as a primary point of contact for external vendors, including CROs, central labs, imaging providers, and eClinical platforms.
- Monitor vendor deliverables and timelines, escalating issues as needed to ensure trial continuity.
- Support contract tracking, invoice processing, and vendor onboarding documentation.
Operational & Administrative Support
- Assist in study start-up, conduct, and close-out activities across multiple trials.
- Maintain and update study trackers (e.g., enrollment, site activation, document status, deviations).
Cross-Functional Collaboration
- Work closely with internal stakeholders in clinical development, regulatory affairs, quality assurance, and data management.
- Support internal and external meeting coordination, including agenda preparation, minute-taking, and action item follow-up.
- Participate in audits and inspections, providing documentation and logistical support.
Process Optimization
- Contribute to the development and refinement of SOPs, templates, and workflows tailored to a small company setting.
- Identify and implement efficiency improvements in clinical operations and vendor management.
Qualifications: Education & Experience
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
- Minimum of 3 years of experience in a CTA or similar role, preferably within a biotech, pharma, or CRO setting.
- Experience working in small company environments or with multiple external vendors is highly desirable.
- Familiarity with Phase I–III clinical trials.
- Strong understanding of ICH-GCP, clinical trial processes, and regulatory requirements.
- Proficiency with eTMF systems (e.g., Veeva Vault, Trial Interactive) and Microsoft Office tools.
- Excellent attention to detail, organization, and time management.
- Strong written and verbal communication skills.
- Ability to work independently, manage multiple priorities, and thrive in a lean, cross-functional team.
- Fluency in English (written and spoken); additional languages are a plus.
Department: Clinical Operations Seniority level
- Seniority level
Mid-Senior level Employment type
- Employment type
Full-time Job function
- Job function
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