We are seeking a Clinical Research Associate to join a fast growing Clinical Operations team at AVEO. The incumbent will have the following responsibilities: Independently perform all types of monitoring visits and/or co-monitors with CRO/contract monitors to ensure quality site conduct and data entry Ensure GCP and local regulatory compliance Conduct review and approval of Site activation Demonstrates independent site management capabilities (compliance, deliverables, relationship, and troubleshooting) Track study progress ensuring timely data collection, monitoring, and query resolution Oversee site compliance with study protocol Assist in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials Review monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensure sponsor oversight Ensure timely safety reporting at assigned investigative sites Participate in data listings review
Qualifications: BS/BA degree or equivalent (background in life sciences preferred) 2+ yrs of industry experience (biotech/pharma/ CRO) as a monitor At least 1 year oncology monitoring experience Strong understanding of ICH, GCP, and relevant regulatory requirements Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint. Ability travel up to 20% of time
We welcome your expertise, your insight and your enthusiasm to help us develop and commercialize novel drugs that bring new hope to cancer patients.
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AVEO is an Equal Employment Opportunity employer that values the strength diversity brings to the workplace.
AVEO Oncology (NASDAQ: AVEO) AVEO Oncology (NASDAQ: AVEO) is Passionate in Our Pursuit of Improving the Lives of Patients with Cancer. We are united in our efforts to provide patients with reasons to believe that they can receive effective treatments while carrying on with their daily living. AVEO Oncology is founded on a unique drug discovery and development approach called the Human Response Platform™. With it, we aim to translate cancer biology insights into next generation therapeutics targeted to specific patients living with cancer who will benefit most. The Human Response is more than a novel biology platform – it is our way of responding to the needs of the cancer community with integrity, fierce determination and compassion combined with the confidence that we will transform the lives of those impacted by cancer. This is the AVEO Way – The Human Response.
AVEO Oncology does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AVEO Oncology must first contact the staffing group at email@example.com. Only approved staffing vendors will be allowed to provide services to AVEO Oncology. Unsolicited resumes will be deemed the property of AVEO Oncology to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AVEO.
Monster - 22 months ago