Senior Clinical Research Associate – Oncology

Full TimeRemoteTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

2 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs) and study protocols • Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks. • Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders • Provide Monitoring expertise, mentoring and training to less experienced team members as required • Build positive working relationships and proactively seek feedback from site teams (e.g., Principal Investigators, Study Coordinators, Pharmacists, Site Administration) • Partner with study teams and sites in conducting site outreach activities, including patient recruitment and retention strategies • Provide input and lead cross-functional teams through the process to determine monitoring strategy (risk-based monitoring) for studies as required • Use regional knowledge to localize study processes and documents where possible • Represent Monitoring at Investigator Meetings as required • Perform other tasks as required

Job Requirements

  • 5+ years monitoring experience in clinical research experience required (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO))
  • Oncology monitoring experience required
  • Travel as required, to include domestic and international
  • Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
  • Demonstrates ability to work independently and in a team environment
  • Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)
  • Excellent oral and written communication skills and strong organizational abilities

Benefits

  • N/A

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