Welcome to Thermo Fisher Scientific! We are a leading global biotechnology company dedicated to helping our customers accelerate life sciences research and improve patient outcomes. We are currently seeking a highly motivated Clinical Research Associate (CRA) I/II to join our team in the Field Service Provider (FSP) department. In this role, you will play a crucial part in supporting clinical trials and ensuring regulatory compliance in accordance with company and industry standards. We are looking for individuals with a strong background in clinical research and a passion for making a positive impact in the healthcare industry. If you are a detail-oriented and enthusiastic professional with a drive for excellence, we encourage you to apply for this exciting opportunity.
- Conduct clinical site visits to ensure compliance with company and industry standards.
- Monitor and track progress of clinical trials, including data collection and analysis.
- Communicate with study sites and investigators to ensure proper documentation and adherence to protocol.
- Ensure all regulatory requirements are met and maintained throughout the duration of the trial.
- Assist in the development and review of study protocols, informed consent forms, and other study-related documents.
- Collaborate with cross-functional teams to ensure smooth execution of clinical trials.
- Maintain accurate and up-to-date records of all study activities and documentation.
- Conduct training and provide support to site personnel on study protocols and procedures.
- Participate in site selection, initiation, and close-out activities.
- Identify and resolve any issues or discrepancies during the course of the trial.
- Stay current with industry regulations and guidelines related to clinical research.
- Assist in the preparation and submission of study-related documents to regulatory authorities.
- Provide timely and accurate updates to project managers and other team members.
- Participate in team meetings and provide input on study progress and potential issues.
- Demonstrate a high level of professionalism and represent the company in a positive manner during interactions with study sites and investigators.
Bachelor's Or Master's Degree In A Relevant Scientific Field, Such As Biology, Chemistry, Or Pharmacy.
At Least 2-3 Years Of Experience As A Clinical Research Associate (Cra) In A Pharmaceutical, Biotech, Or Cro Setting.
Strong Knowledge Of Ich-Gcp Guidelines And Fda Regulations, With Previous Experience Conducting Clinical Trials In Accordance With These Standards.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Build Rapport With Study Site Personnel.
Familiarity With Electronic Data Capture (Edc) Systems And Other Clinical Trial Software, As Well As Proficiency In Microsoft Office And Data Management Tools.
Data Management
Regulatory compliance
Clinical monitoring
Patient Recruitment
Protocol Review
Site Selection
Safety Reporting
Protocol Adherence
Study Start-Up
Query Resolution
Investigator Liaison
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a CRA I/II - FSP is between $60,000-$90,000 per year. This may vary depending on factors such as location, experience, and the specific company.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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