Parexel FSP is looking for a Senior CRA in the MidWest!

Experience in CNS and /or Oncology preferred.

Job Purpose:

The Clinical Research Associate (CRA) will be a member of the Sponsor Monitoring team and provide monitoring expertise to individual clinical trials and/or programs

Key Accountabilities

Oversight of activities

• 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

Collaborative relationships

• Collaborates effectively with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions that align with project goals and operational efficiency.

Compliance with Parexel standards

• Complies with required training curriculum

• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Travel as required, to include domestic and international
• 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
• Ability to speak and understand multiple languages preferred

Knowledge and Experience:

• Relevant clinical research experience (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO), medical device)
• Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
• Experience in CNS and / or oncology preferred
• The Clinical Research Associate can be staffed at multiple levels
  • Clinical Research Associate I will have up to 2 years of relevant experience as assessed by the client
  • Clinical Research Associate II will have a minimum of 2 years and up to 5 years of relevant experience as assessed by the client
  • Senior Clinical Research Associate requires 5 or more years of relevant experience as assessed by the client

Education:

• BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred

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