Parexel FSP is seeking a CRA/SrCRA with Early Development experience in Nebraska/Midwest.

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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