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Senior Clinical Research Associate - FSP

April 30, 2026

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.KEY RESPONSIBILITIES:Site Management and Monitoring Activities:<ul><li>Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and sponsor SOPs.</li><li>Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.</li><li>Partner with Clinical Trial Liaison (CTL) and other sponsor functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables.</li><li>Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.</li><li>Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements</li></ul>Oversight Monitoring:<ul><li>Prepare and maintain Oversight Monitoring Plan</li><li>Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits</li><li>Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA</li><li>Review site source documentation and verify accurate data capture (ALCOA principles)</li><li>Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items</li></ul>Documentation and Reporting:<ul><li>Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting.</li><li>Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner.</li><li>Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents).</li></ul>Issue Management and Escalation:<ul><li>Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary.</li><li>Track, trend, and report issues, escalating them to the appropriate teams when required.</li></ul>Collaboration and Communication:<ul><li>Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs.</li><li>Actively participate in team meetings and process improvement initiatives to enhance study outcomes.</li></ul>Inspection Readiness<ul><li>Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables</li></ul>JOB REQUIREMENTS:Bachelor's degree (or equivalent)Experience:<ul><li>Minimum of 5 years of related experience for Snr CRA</li><li>Strong analytical problem-solving skills and critical thinking abilities.</li><li>Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).</li></ul>Skills:<ul><li>Effective communication and interpersonal skills to build relationships internally and externally.</li><li>Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories.</li><li>Demonstrated ability to deliver clear and concise written reports.</li><li>Effective prioritisation and time management skills</li></ul>

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Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

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9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

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This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...