Senior Clinical Research Associate/Clinical Research Associate - FSP

About the Role

As a member of the study team, you will contribute to the selection of potential investigators and participate in site qualification visits. You will also train, support, and advise investigators and site staff on study-related matters, including Risk-Based Quality Management principles. Your role will require you to actively participate in Local Study Team meetings and contribute to National Investigators meetings as needed.

Parexel's commitment to improving global health is evident in its deep conviction in the work that it does. Every employee, regardless of their role, contributes to the development of therapies that ultimately benefit patients. This role is an opportunity to make a real difference in people's lives while working with a company that prioritizes empathy, commitment, and making a difference.

What You Will Do

• Contribute to the selection of potential investigators and participate in site qualification visits
• Train, support, and advise investigators and site staff on study-related matters
• Monitor study conduct and ensure compliance with Client Procedural Documents, international guidelines, and local regulations
• Prepare and initiate sites, including collection, preparation, review, and tracking of documents for the application process
• Ensure sites are inspection-ready at all times and participate in Local Study Team meetings
• Initiate, monitor, and close study sites in compliance with Client Procedural Documents
• Share information on patient recruitment and study site progress within the Local Study Team
• Drive performance at study sites and proactively identify and resolve study-related issues
• Update CTMS and other systems with data from study sites as per required timelines
• Manage study supplies, drug supplies, and drug accountability at study sites

What We Are Looking For

• Experience in clinical research, preferably as a Clinical Research Associate
• Strong understanding of ICH-GCP guidelines and relevant local regulations
• Proficiency in Excel and other Microsoft Office applications
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong attention to detail and organizational skills
• Experience with CTMS and other clinical trial management systems
• Strong analytical and problem-solving skills

Nice to Have

• Experience with Risk-Based Quality Management principles
• Knowledge of regulatory requirements and guidelines
• Certification in clinical research or a related field
• Experience with study start-up and regulatory maintenance

Benefits and Perks

• Opportunity to work on a wide range of clinical trials and studies
• Collaborative and dynamic work environment
• Flexible working hours and remote work options
• Professional development and training opportunities
• Competitive compensation and benefits package
• Access to cutting-edge technology and tools
• Recognition and reward for outstanding performance

• Make sure to highlight your experience with Excel and other Microsoft Office applications in your application.
• Emphasize your strong communication and interpersonal skills, as these are crucial for success in this role.
• Be prepared to talk about your experience with ICH-GCP guidelines and relevant local regulations.
• Show examples of your attention to detail and organizational skills in your previous work experience.
• Research Parexel's values and mission, and be prepared to explain why you're a good fit for the company culture.
• Practice your problem-solving skills, as you'll be expected to proactively identify and resolve study-related issues.
• Consider obtaining certification in clinical research or a related field to increase your chances of standing out as a candidate.