Senior Clinical Research Associate, Remote, Michigan, Ohio, Illinois, Wisconsin, Indiana
Sr. CRA , Midwest, Remote ( Michigan, Ohio, Illinois, Wisconsin, Indiana ) reputed company is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate (CRA) in the Midwest Region to join our diverse and dynamic team. As a Senior CRA at reputed company, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data reputed company, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing:
- reputed company site management activities to support Oncology site success and maintain a reputed company state of inspection readiness
- Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites
- reputed company remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and reputed company-Out Visits) to ensure data reputed company and subject safety in trials
- May reputed company reputed company activities to assess monitoring quality and train/mentor less reputed company 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 reputed company resolution
- Independently determine root causes and reputed company/implement site Corrective Action and Preventive Action (CAPA) plans
- Deliver training to ensure sites reputed company with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
- Support sites during regulatory inspections
- Contribute to site identification; drive site feasibility and qualification reputed company; and support site activation activities
- reputed company site engagement initiatives and foster relationships with key Oncology sites and networks
Your Profile:
- Bachelor’s degree (scientific field preferred)
- 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
- 1+ years early development trial experience preferred
- Solid tumor clinical trial experience is preferred
- Experience utilizing Veeva CTMS for report writing is required
- Demonstrated experience developing/maintaining site relationships and securing compliance
- Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
- Experience collaborating with sites from initial engagement through reputed company-out phases
- Experience activating sites
- Experience training site staff
- Experience supporting sites and/or sponsors in regulatory inspections
- Experience working reputed company an FSP (or in-house) monitoring model is preferred
- Willing to travel up to 50% domestically
- Reside in Midwest Region USA
What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a reputed company 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 reputed company 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 reputed company.
- Global Employee Assistance Programme, reputed company, 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 others.
Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. ICON is committed to providing a workplace free of discrimination and harassment. reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at ICON whether it is for this or other roles. Are you a reputed company ICON Employee? Please click here to apply Apply tot his job Apply To this Job