Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSCRC0

Position Description

This position is full-time. (Part-time, contract, and contract-to-permanent candidates will be considered, depending upon experience.)

• Successfully support the Clinical Solutions Team in the execution of the clinical development programs in accordance with operating timelines, GCP-compliant Standard Operating Procedures, and other applicable SOPs and regulations
• Uphold processes that ensure the absolute integrity of clinical study data sets, analysis, and Clinical Study Reports
• Support the Clinical Solutions Practice Leader, and Team with preparation, presentations, and travel arrangements for internal and external review meetings
• Support the Clinical Solutions Team in the compilation, organization, and production of IRB submissions, and other controlled documentation
• Assist the Clinical Solutions Team and Clinical Research Coordinators in supporting assigned sites to ensure adequate recruitment and obtaining informed consent following the inclusion/exclusion criteria, Good Clinical Practices, and all applicable SOPS and regulations
• Assist the Clinical Solutions Team and Clinical Research Coordinators in providing appropriate support to clinical investigators and additional study site personnel
• Support the Clinical Solutions Team in recording, retrieving, and processing patient data following good clinical practices to complete Case Report forms adequately and ensure the resolution of study data queries in a timely manner
• Carry out all other tasks and responsibilities related to the position
• Project a mature, professional image and provide responsive, meaningful, high-quality clinical operations support and follow-up to client inquiries
• Support and maintain a daily clinical operations workplan and calendar that tracks important activities, milestones, and deadlines
• Travel (US and international) of ~5% - 20%
• Support the maintenance of documentation, filing, tracking, and information retrieval systems
• Develop and maintain the requisite computer skills to effectively utilize state-of-the-art office equipment and systems (Ongoing testing and certifications may be expected.)
• Understand and comply with Standard Operating Procedures and work instructions
• Perform other duties as may be assigned by the Clinical Solutions Practice Leader, and Team
• Report to the Clinical Solutions Practice Leader, and Team

• Successful professional or contract research clinical operations experience with leading biomedical industry firms preferred (Entry level candidates will be considered, depending upon experience.)
• Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
• Undergraduate BS or BA degree in nursing, an allied health profession, or life sciences from a leading university preferred (Candidates with relevant academic experience will be considered, depending upon experience.)
• Comprehensive understanding of the medical product development process
• Certifications in Microsoft Windows and Office applications a plus
• Excellent presentation and communication (both oral and written) skills
• Excellent time management, planning, and teamwork skills
• Must be willing to work hours as needed to meet deadlines and needs

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