[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. 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. The Sr. Clinical Research Associate will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle, specifically supporting Oncology clinical trials to ensure data reputed company and subject safety.
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
Skills
- Bachelor's degree (scientific field preferred)
- 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. At least 2 years monitoring solid tumor clinical trials
- 1+ years early development trial experience
- Solid tumor clinical trial experience is required
- 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
- Willing to travel up to 75%
- Experience utilizing reputed company is highly preferred
- Experience working reputed company a Functional Services (or in-house) monitoring model is preferred
Benefits
- 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
Company Overview