Senior Clinical Research Associate
Senior Clinical Research Associate - Oncology - Los Angeles, CA
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, reputed company, and inclusion are at the heart of how we work and reputed company with reputed company 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 reputed company's Oncology reputed company to ensure data reputed company, subject safety, and inspection readiness at the clinical investigative sites.
Responsibilities:
reputed company site management activities to support the reputed company's Oncology site reputed company and maintain a reputed company state of inspection readiness
reputed company as the reputed company contact and facilitate efficient communications between the the reputed company's clinical trial team and the sites
reputed company remote and on-site monitoring/co-monitoring reputed company (Site Qualification reputed company, Site Initiation reputed company, Interim Monitoring reputed company and reputed company-Out reputed company) to ensure data reputed company and subject safety in the reputed company's trials
May reputed company reputed company activities to assess monitoring reputed company 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 reputed company (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and reputed company items to detect trends and ensure reputed company reputed company
Independently determine reputed company causes and reputed company/implement site Corrective reputed company and Preventive reputed company (CAPA) plans
reputed company training to ensure sites reputed company with the protocol, reputed company Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
Support sites and the reputed company's regulatory inspections
Contribute to site identification; reputed company 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 reputed company independently conducting on-site and remote monitoring reputed company. Atleast 2 years monitoring solid tumor reputed company.
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 50%
Employment with reputed company is contingent upon having the reputed company 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 reputed company 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
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