Clinical Research Associate (CRA)
AI in this role
Clinical Research Associate providing administrative and regulatory support for clinical trials and maintaining compliance records.
Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients. You will play a crucial role in improving patients' lives by ensuring the accuracy and integrity of clinical data. Your work will directly impact the development of new treatments and therapies, helping to bring innovative solutions to patients in need.
What You Will Achieve
In this role, you will:
- Coordinate and support clinical trial activities, assisting managers in their execution.
- Contribute to project tasks and milestones, organizing work to meet deadlines.
- Work in a structured environment using established procedures, seeking guidance from colleagues.
- Maintain the Pfizer Trial Master File (PTMF) in compliance with ICH-GCP and SOPs, and ensure team members update tracking and files as needed.
- Timely update trial and site information in the Corporate Clinical Trial Registry and support Clinical Trial Applications to ethics committees and regulatory authorities.
- Provide administrative support for protocols and Informed Consent Documents (ICD) to global Project Managers and Study Managers, assisting with activities within set timelines.
- Develop and maintain local tracking spreadsheets for study-related documents, data, and activities, prepare supportive materials for sites, attend training programs, and identify process improvements for inspection readiness and PTMF compliance.
Here Is What You Need (Minimum Requirements):
- BA/BS with any years of experience
- Demonstrated ability to introduce new ideas and knowledge on all relevant Standard Operating Procedures
- Ability to prioritize multiple tasks and develop strategies for the completion of all required activities
- Strong organizational skills and attention to detail
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Excellent written and verbal communication skills
Bonus Points If You Have (Preferred Requirements):
- Experience in the management of clinical trial and regulatory documents
- Solid understanding of International Conference on Harmonization Good Clinical Practices and local regulations
- Familiarity with applications used in clinical trials
- Experience with electronic data capture systems
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical
How we rate this
Clinical Research Associate (CRA) at Pfizer rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Open the description and count.
Prepare for this job
A free preview built only from this posting: what it asks for, what you could be asked in an interview, and how to adjust your resume.
Skills and AI tools this role asks for
Questions you could be asked
- How do you think about the risk of an AI system in this kind of role failing silently?
- Tell me about a project where clinical trials was part of your work. What did you do?
- Tell me about a project where regulatory compliance was part of your work. What did you do?
- Tell me about a project where administrative support was part of your work. What did you do?
- Tell me about a project where trial master file was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: AI Safety, Clinical Trials, Regulatory Compliance, Administrative Support, and Trial Master File. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them — a tool named with nothing behind it rarely survives a human read.
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