Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - Washington DC reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data reputed company, subject safety, and inspection readiness at the clinical investigative sites. Responsibilities: reputed company site management activities to support the client's Oncology site reputed company and maintain a reputed company state of inspection readiness Act as the primary contact and facilitate efficient communications between the client's 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 the client's 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 and the client's 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

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 reputed company 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 reputed company-out phases Experience activating sites Experience training site staff Experience supporting sites and/or sponsors in regulatory inspections Experience working reputed company a Functional Services (or in-house) monitoring model is preferred Willing to travel up to 75% Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company 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 here. Salary reputed company $110,520.00-$138,150.00 Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job