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Clinical Research Associate - Oncology - Kansas/Central

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What will you be doing?• Works on multiple oncology trials• Quality of life focus wtih Regional Travel• Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team• Acts as Lead SM-training other SMs on study• Develops site start up documents for studies including SIV agenda• Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)• Represents LTMs or SMs on SMTs/meetings• Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial• Supports country budget development and/or contract negotiation in liaison with CCS colleagues• Assists with ASV• Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.Interfaces – Primary/Other:• *• Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.• Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)Qualifications Needed:• Based in Kansas near a major airport)• Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences• Have a minimum of 2 years’ experience in monitoring pharmaceutical industry clinical trials• Have a minimum of 1-3 years' experience monitoring Oncology trials• Knowledge of several therapeutic areas, with oncology an asset but not a requirement.• Analytical/risk-based monitoring experience is an asset• Ability to actively drive patient recruitment strategies at assigned sites• Ability to partner closely with investigator and site staff to meet all of our study timelines• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.• Need to travel up to 50%• To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa statusWhat ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:• Various annual leave entitlements• A range of health insurance offerings to suit you and your family’s needs• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being• Life assurance• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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What You Should Know About Clinical Research Associate - Oncology - Kansas/Central, ICON

As a Clinical Research Associate - Oncology at ICON, based in Kansas City, MO, you will play a pivotal role in advancing oncology research. Join a company that stands as the world’s largest and most comprehensive clinical research organization, leveraging healthcare intelligence to drive meaningful results in patient care. In this position, you'll be involved in multiple oncology trials that focus on enhancing the quality of life for patients. Your responsibilities will include developing essential study documents, mentoring junior team members, and serving as a lead subject matter expert. If you have a passion for ensuring that clinical trials run smoothly and effectively, your expertise will shine when you collaborate with investigators and site staff to meet study timelines and drive patient recruitment strategies. The role demands strong communication skills for both remote and face-to-face interactions and requires you to travel up to 50%. With a minimum of 2 years of experience in monitoring clinical trials, specifically in oncology, you will bring valuable insights into various therapeutic areas. At ICON, we value diversity and high performance; we invest in our teams through training and a supportive environment, making us a great place to grow your career while making a significant impact in the field of clinical research.

Frequently Asked Questions (FAQs) for Clinical Research Associate - Oncology - Kansas/Central Role at ICON
What are the responsibilities of a Clinical Research Associate - Oncology at ICON?

As a Clinical Research Associate - Oncology at ICON, your primary responsibilities include overseeing multiple oncology trials, mentoring junior team members, developing site startup documents, and representing study managers in key meetings. You will actively drive patient recruitment strategies and work alongside investigators and site staff to ensure timelines are met. Your role also involves collaborating with regional teams to support budget development and contract negotiations, making it critical for the success of clinical studies.

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What qualifications are required for the Clinical Research Associate - Oncology position at ICON?

To qualify for the Clinical Research Associate - Oncology position at ICON, candidates must hold a minimum of a B.Sc., R.N., or an equivalent degree, preferably in Biological Sciences. Additionally, a minimum of two years of monitoring pharmaceutical industry clinical trials is required, along with one to three years' experience in monitoring oncology trials specifically. Applicants should also have knowledge of good clinical practice and local regulatory requirements.

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What is the travel requirement for the Clinical Research Associate - Oncology role at ICON?

The Clinical Research Associate - Oncology role at ICON requires candidates to travel up to 50% of the time. This travel may include visits to clinical trial sites to ensure compliance, support recruitment efforts, and foster relationships with investigators and site personnel. Your ability to manage travel effectively while ensuring the success of the trials will be crucial in this position.

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What skills are important for a Clinical Research Associate - Oncology at ICON?

Essential skills for a Clinical Research Associate - Oncology at ICON include strong communication and influencing abilities, time management, and analytical thinking. You should also possess a solid understanding of clinical trial systems and databases, including CTMS and EDC systems. Moreover, having a proactive attitude towards driving patient recruitment and the ability to collaborate in both remote and in-person settings will greatly benefit your success in this role.

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What kind of support does ICON provide to its Clinical Research Associates?

ICON provides extensive support to its Clinical Research Associates, focusing on professional development and well-being. The company offers comprehensive benefits such as diverse health insurance options, retirement planning, and a Global Employee Assistance Programme. Additionally, there are training opportunities for skills enhancement, mentoring programs, and a culture that prioritizes inclusion and support for all employees.

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Common Interview Questions for Clinical Research Associate - Oncology - Kansas/Central
Can you describe your experience with oncology clinical trials?

When answering this question, provide specific examples of the oncology trials you've worked on, including your role, responsibilities, and any challenges you faced. Highlight how you contributed to patient recruitment strategies and compliance with study protocols, showing your understanding of the unique aspects of oncology research.

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What methods do you use to ensure effective communication with site staff?

Discuss your strategies for maintaining open lines of communication with clinical site staff. You might mention regular meetings, updates, and feedback sessions as well as your adaptability in using various communication tools, whether remote or in person, to foster strong working relationships.

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How do you prioritize tasks when managing multiple trials?

Explain your approach to prioritizing tasks, such as evaluating study timelines, deadlines, and the critical nature of each task. Mention specific organizational tools or techniques you employ, like to-do lists or project management software, to ensure that you always adhere to timelines without compromising the quality of your work.

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What experience do you have with regulatory compliance in clinical trials?

Share your familiarity with good clinical practice, ICH guidelines, and local regulatory requirements. Provide examples of past experiences where you ensured compliance during trials and how you prepared for audits or inspections to demonstrate your commitment to high standards in research.

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Can you discuss a particularly challenging situation you've faced in a trial and how you handled it?

Choose a specific example that showcases your problem-solving abilities and readiness to adapt under pressure. Discuss how you assessed the situation, the steps you took to resolve the issue, and what you learned from the experience that could benefit future trials.

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What strategies do you employ to drive patient recruitment?

Discuss the various strategies you have implemented to enhance patient recruitment, such as engaging with site staff to develop outreach programs, creating informational materials, and leveraging local community resources. Highlighting any success stories can add weight to your answer.

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How do you handle conflicts between site staff and the project team?

Talk about your conflict resolution skills and your approach to addressing disagreements. Explain how you encourage open dialogue, seek to understand each party's perspective, and find compromises that align everyone's goals, ultimately fostering a collaborative atmosphere.

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What is your experience with clinical trial management systems (CTMS)?

Describe your familiarity with different CTMS platforms, outlining your hands-on experience and how you have utilized such systems to streamline processes, track progress, and maintain documentation for trials. Providing examples of how this has contributed to successful studies will reflect positively on your tech-savvy expertise.

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How do you ensure data integrity during a clinical trial?

Elaborate on the strategies you employ to maintain data integrity, such as regular audits, double-checking data entry, and training site staff on proper data handling techniques. Connecting your actions to real-world outcomes can reinforce your capability and diligence.

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Why do you want to work with ICON as a Clinical Research Associate - Oncology?

Express your enthusiasm for the company’s mission and values, emphasizing how your career goals align with ICON’s commitment to advancing healthcare through research. Highlight your passion for oncology research and the opportunity to impact patient lives positively.

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ICON is a values-driven, people-centric organisation. Our core values are not unique to ICON but we use these guiding pillars to stay accountable for the work that we do. We are passionate and driven and we want to deliver for our patients, our pe...

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December 6, 2024

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