Oncology Senior Clinical Research Associate- FSP

Parexel • Remote (Any Region, United States of America) • 1w ago

Parexel FSP is looking for a Senior CRA/CRA in the United States!

Oncology experience required.

Key Accountabilities

Supporting Activities

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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