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Sr. Clinical Research Associate

Cambridge, MA

Posted: 05/20/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2350

Our client is seeking a qualified, enthusiastic and collaborative candidate for the newly created Senior Clinical Research Associate job opportunity to support their Project Managers and take on lead responsibilities within their oncology-focused clinical studies. This is a great opportunity for an experienced CRA to move into a Senior CRA role and get hands-on experience conducting and overseeing many aspects of international oncology clinical trials.  The right candidate will bring their skills and positive attitude to a small but strong Clinical Operations team.

Responsibilities Include:
  • Independently perform all types of monitoring and/or co-monitors visits with CRO monitors to ensure quality site conduct and data entry
  • Performs on-site and remote monitoring and oversight activities using systems, tools, and working practices to ensure that the data generated at the site are complete and accurate
  • Ensure FDA, GCP and local regulatory compliance
  • Conduct review and approval of sites activation
  • Demonstrates independent site management capabilities (compliance, deliverables, relationship, and troubleshooting)
  • Track study progress ensuring timely study and site start-up, 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
  • Study Management responsibilities including CRO management and oversight

Requirements / Qualifications:
  • BS/BA degree or equivalent (background in life sciences preferred)
  • 5+ years of industry experience (biotech/pharma/CRO) as a monitor preferred
  • At least 2 years oncology monitoring experience preferred
  • Has demonstrated the ability to manage timelines and vendors
  • Strong understanding of ICH, GCP, and relevant regulatory requirements
  • Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint.
  • Ability to travel up to 50% of time

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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