About Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Operating in over 100 countries, AstraZeneca’s innovative medicines are used by millions of patients worldwide. Our mission is to push the boundaries of science to deliver life-changing medicines. We are driven by a commitment to patients and a collaborative culture that fosters innovation, courage, and a relentless pursuit of scientific excellence. At AstraZeneca, you’ll be empowered to make a meaningful difference, contributing to breakthroughs that transform healthcare and improve lives.
Job Description
We are seeking a highly motivated and detail-oriented Clinical Trial Assistant (CTA) to join our dynamic Clinical Operations team in Port Malabar, Palm Bay, FL. This is an exciting opportunity for an individual with a passion for clinical research and a desire to contribute to the development of life-changing medicines. As a CTA, you will play a crucial role in the successful execution of clinical trials, providing essential administrative and operational support to our Clinical Study Teams. You will be instrumental in maintaining trial documentation, managing systems, and ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements. This position offers an immediate start, requiring an individual who is proactive, organized, and capable of thriving in a fast-paced environment. You will support multiple studies across various therapeutic areas, gaining invaluable experience in the pharmaceutical industry. This role is perfect for someone looking to build a strong foundation in clinical research and grow within a leading global biopharmaceutical company dedicated to innovation and patient impact. Your ability to meticulously manage documents, communicate effectively, and adapt to evolving priorities will be key to your success and our collective mission to deliver groundbreaking treatments. Join us and contribute directly to advancing science and patient care.
Key Responsibilities
- Provide administrative support to Clinical Study Teams, including scheduling meetings, preparing agendas, and drafting meeting minutes.
- Assist in the preparation, distribution, and archiving of clinical trial documents, ensuring accuracy and compliance with SOPs and regulatory guidelines.
- Maintain and update various clinical trial tracking systems and databases (e.g., CTMS, eTMF), ensuring data integrity and timely input.
- Support the management of Investigator Site Files (ISF) and Trial Master Files (TMF) for completeness, quality, and audit readiness.
- Assist with the onboarding and offboarding of clinical trial personnel, managing access to systems and documentation.
- Coordinate the shipment and tracking of clinical trial supplies and materials to investigator sites.
- Facilitate communication between the clinical study team, investigative sites, and vendors as needed.
- Participate in quality control checks of clinical trial documentation and systems.
- Support the preparation for internal and external audits and inspections.
- Assist in the development and review of study-specific documents, such as informed consent forms and case report forms.
Required Skills
- Bachelor's degree in a life science or related field.
- Minimum of 1 year of experience in clinical research, preferably in a pharmaceutical company or CRO setting.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Familiarity with Good Clinical Practice (GCP) and regulatory requirements.
- Exceptional organizational skills and attention to detail.
- Strong written and verbal communication skills.
- Ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
Preferred Qualifications
- Experience with Electronic Trial Master File (eTMF) systems.
- Knowledge of Clinical Trial Management Systems (CTMS).
- Previous experience supporting multiple clinical trials simultaneously.
- Certification in clinical research (e.g., CCRP).
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off, including holidays and vacation.
- Competitive 401(k) matching program.
- Tuition reimbursement and professional development opportunities.
- Life and disability insurance.
- Employee assistance program.
- On-site fitness centers or wellness program reimbursement (where applicable).
- Employee discount programs.
- Opportunities for career growth and advancement within a global organization.
How to Apply
Interested candidates are encouraged to apply directly through our careers portal. Please click on the application link below to submit your resume and cover letter, outlining your relevant experience and why you are the ideal candidate for this role. We look forward to reviewing your application and exploring how your skills and passion can contribute to AstraZeneca’s mission.