Clinical research associate II

May 26, 2026

Other Jobs To Apply

No other job posts for this day.

CRA II - oncology unblinded - US remote ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. What You Will Do:<ul><li>Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. </li><li>Develops meaningful site relationships through consistent collaborative communication and engagement. </li><li>May participate in site feasibility and/or pre-trial site assessment visits </li><li>Attends/participates in investigator meetings as needed. </li><li>Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. </li><li>Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. </li><li>Ensure site compliance with study protocol, ICH-GCP, and local/country regulations </li><li>Ensure ongoing adequacy of site (facilities, staff) for trial conduct </li><li> Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA </li><li>Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. </li><li>Ensures site non-IMP study supplies are adequate for trial conduct. </li><li>Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. </li><li>Oversees the appropriate destruction of clinical supplies. </li><li>Ensures site staff complete data entry and resolve queries within expected timelines. </li><li>Ensures validity and completeness of data collected at trial sites </li><li>Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. </li><li>Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. </li><li>Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. </li><li>Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. </li><li>Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. </li><li>Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. </li><li>Prepares trial sites for close out, conduct final close out visit. </li><li>Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. </li><li>May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. </li></ul>Your Profile:<ul><li>BA/BS degree with ≥3 years of experience in pharmaceutical related drug development or direct equivalent experience. </li></ul><ul><li>Three years site monitoring and/or site management experience. </li><li>Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. </li><li>Strong critical thinking and problem solving skills. </li></ul><ul><li>Strong IT skills in appropriate software and company systems. </li></ul><ul><li>Willingness to travel up to 40% with overnight stay away from home (though the goal is to focus on remote monitoring)</li></ul><ul><li>Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language. </li></ul><ul><li>Good written and oral communication. </li><li>Oncology experience highly preferred</li><li>Experience as an unblinded monitor required</li></ul> Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:<ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul> Benefits may vary depending on role and location. Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers. Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer">here</a>.Are you a current ICON Employee? Please click <a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a> to apply

Back to blog

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?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

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...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

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...

DISCLAIMER