Early Dev Senior Clinical Research Associate- Nebraska

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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#LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.