Early Dev Senior Clinical Research Associate- Nebraska
United States of America, Remote 职位编号 R0000034522 类别 Clinical Trials关于这个职位
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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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.