Senior Clinical Research Associate

Responsibilities: Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness Act... Senior Clinical Research Associate job in US, New York, NY, Rochester | ICON JUMP TO CONTENT Manage your application Shortlist 0 Search Careers in ICON Careers We encourage our people to seize the opportunity to bring flexibility, innovation and determination to every situation. By doing this, our people build exciting and rewarding careers, deliver results to help bring life-changing medicines and devices to market and maintain ICON’s success as an industry leader. View jobs at ICON About Icon Overview of Service Lines Job Categories ICON Full Service Full Service Full-service roles offer the opportunity to work on projects and programmes on behalf of the world’s most innovative pharma, biotech and medical device companies. 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ICON is committed to recruiting top talent while also fostering a culture of learning and development within the organization. Building a Successful Clinical Research Resume Landing Your First Job in Clinical Research Internships Graduate Opportunities Hints & Tips for Graduates graduate What does full service mean for you? Integer posuere erat a ante venenatis dapibus posuere velit aliquet. Duis mollis, est non commodo luctus, nisi erat porttitor ligula. Read more Career Resources Our Culture Application Process AI Usage Policy Our Mission & Values Senior Clinical Research Associate Location: New York, New Jersey, Rochester, Philadelphia, PA Reference: JR153420 Categories Clinical Monitoring __vacancyopjusttionswidget.opt-Business Area__ ICON Strategic Solutions (FSP) __vacancyopjusttionswidget.opt-Remote Working __ Remote About the role This vacancy has now expired. Please click here to view live vacancies. Senior Clinical Research Associate - Oncology - New York At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. Responsibilities: Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs Promptly document monitoring activities and submit/approve visit reports Manage site essential document collection and TMF reconciliation with site files Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations Support sites and the client's regulatory inspections Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities Lead site engagement initiatives and foster relationships with key Oncology sites and networks Qualifications Bachelor’s degree (scientific field preferred) 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. 1+ years early development trial experience Solid tumor clinical trial experience is required Experience utilizing Veeva systems is highly preferred Demonstrated experience developing/maintaining site relationships and securing compliance Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology Experience collaborating with sites from initial engagement through close-out phases Experience activating sites Experience training site staff Experience supporting sites and/or sponsors in regulatory inspections Experience working within a Functional Services (or in-house) monitoring model is preferred Willing to travel up to 50% What 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 maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here Interested 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. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply Share: Hi, I am Monica and I manage this role Senior Talent Acquisition Business Partner Icon Strategic Solutions View my profile Email [email protected] View my other roles Send me a message First Name * Last Name * Email address * Enquiry * Send Cancel Get Job Alerts! Sign up to receive job updates tailored to your interests. Sign Up Not Ready to Apply? Join our Talent Community for future alerts. Sign up Explore more about ICON About ICON Explore Global Office Locator Explore Benefits & Rewards Explore Inclusion & Belonging Explore Career Pathways Explore Environmental, Social & Governance Explore List #1 Day in the life Suzaita's story - an insight into working in Clinical Research Teaser label A Day In The Life Content type Blogs Publish date 04/05/2023 Summary Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfil Teaser label Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment. Read more by Suzaita Hipolito by Suzaita Hipolito View all Similar jobs at ICON Senior Clinical Research Associate Salary Location Germany, Frankfurt Location Frankfurt Mannheim Remote Working Remote Business Area ICON Strategic Solutions (FSP) Job Categories Clinical Monitoring Job Type Permanent Description As a Senior CRA at ICON Plc, you will oversee and manage clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. 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What You Will Do:You will Reference JR161403 Expiry date 01/01/0001 Author Jaroslav Polák Author Jaroslav Polák Read more Shortlist Save this role Read more Shortlist Save this role CRA 2 Salary Location China, Guangzhou Location Guangzhou Remote Working Remote or Office Business Area ICON Strategic Solutions (FSP) Job Categories Clinical Monitoring Job Type Permanent Description As a CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programmes. What You Will Do:Your role w Reference JR162303 Expiry date 01/01/0001 Author Sally Zeng Author Sally Zeng Read more Shortlist Save this role Read more Shortlist Save this role Privacy Cookie Policy Terms & Conditions Contact ICON plc EEO Statement Reasonable Accommodations Security Notice Netherlands AI Usage Policy for Job Applicants Visit ICONPlc.com &copy ICON. 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