Clinical Trials Associate
About The Position
Attovia Therapeutics, Inc., is seeking a Clinical Trials Associate (CTA) to join our Clinical Operations team, providing operational and administrative support for the planning, startup, execution, and close-out of Attovia-sponsored clinical trials. This role reports to the Head of Clinical Operations or a Clinical Trial Manager (CTM). Working closely with Clinical Trial Managers (CTMs), Clinical Scientists, Quality Assurance, Regulatory Affairs, CROs, and other vendors, the CTA helps ensure studies are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and Attovia Standard Operating Procedures (SOPs). This role is ideal for an organized, detail-oriented individual who enjoys working in a fast-paced biotechnology environment and is interested in building a career in Clinical Operations.
Requirements
- Bachelor's degree in Life Sciences, Nursing, Health Sciences, or related field.
- 1–3 years of experience supporting clinical trials in biotechnology, pharmaceutical, CRO, or academic research environments.
- Working knowledge of ICH-GCP guidelines and clinical research processes.
- Excellent organizational and time management skills.
- Strong written and verbal communication skills.
- High attention to detail and ability to manage multiple priorities simultaneously.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
Nice To Haves
- Experience supporting global Phase 1 or Phase 2 clinical trials.
- Experience with eTMF systems (e.g., Veeva Vault TMF, Wingspan, or similar).
- Familiarity with CTMS, eISF, EDC, or electronic quality management systems.
- Experience working in a small biotechnology company.
- Understanding of GCP inspections and audit readiness activities.
- Exceptional organizational skills with strong attention to detail
- Strong sense of accountability and follow-through on commitments
- Ability to manage and prioritize multiple competing priorities in a fast-paced environment
- Excellent written and verbal communication skills
- Collaborative team player with a proactive approach to problem-solving
- Adaptable and comfortable operating in a dynamic, evolving environment
- Strong customer service orientation with internal and external stakeholders
Responsibilities
- Provide day-to-day operational support for one or more Phase 1–2 clinical studies.
- Assist with study startup activities, including vendor onboarding, essential document collection, and tracking study milestones.
- Support study maintenance activities throughout enrollment, treatment, and follow-up.
- Assist with study close-out activities and Trial Master File (TMF) reconciliation.
- Maintain study trackers, action item logs, and operational dashboards.
- Assist with the management and quality control of electronic Trial Master Files (eTMFs).
- Review documents for completeness, accuracy, and TMF filing readiness.
- Support TMF reconciliation with CROs and vendors.
- Help prepare for TMF audits and inspections.
- Coordinate meetings with CROs, vendors, and internal stakeholders.
- Prepare meeting agendas, capture minutes, and track follow-up actions when needed.
- Monitor completion of assigned action items.
- Support vendor qualification and onboarding activities as requested.
- Assist with development and maintenance of study plans, contact lists, communication plans, and study documentation.
- Coordinate document review and approval workflows.
- Help to maintain study distribution lists and controlled documents.
- Assist with collection and tracking of essential regulatory documentation.
- Support inspection readiness activities.
- Ensure documentation complies with ICH-GCP, company SOPs, and applicable regulations.
- Assist with training documentation and study compliance tracking.
- Work closely with Clinical Trial Managers to support multiple concurrent studies.
- Collaborate with Regulatory Affairs, Clinical Science, Data Management, Biostatistics, Pharmacovigilance, Clinical Supply, Biomarker Operations, and Quality Assurance functions.
- Build productive working relationships with CROs, vendors, and investigator sites.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
