Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.
As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
- Innovative
- Problem-Solver
- Communicator
- Tech-Savvy
- Confident
- Independent
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Compensation
Competitive salaries and bonus structure based on individual metrics.
Responsibilities
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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