Senior Clinical Research Associate - Oncology - FSP

Parexel • Lincoln, NE • 6h ago

Job Summary:

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

Key Accountabilities:

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

Required Knowledge, Skills, and Abilities:

5+ years monitoring experience in clinical research experience required (i.e., biotechnology, pharmaceutical, Contract Research Organization (CRO))

Oncology monitoring experience required

Travel as required, to include domestic and international

Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations

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

Education:

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

LI-REMOTE

EEO 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.

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