Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSCRA2

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 Practice Leader in the execution of 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 compilation, organization, and production of case report forms, protocols, clinical study reports, and other controlled documentation
• Interface with clinical investigators and study site personnel to determine compliance with protocol and regulatory requirements
• Coordinate study management and monitoring activities by managing and interfacing with clinical investigators, study site personnel, client personnel, and the Clinical Solutions Team
• Conduct and coordinate study site qualification, initiation, monitoring, and close-out visits
• Support the generation, development, validation, and resolution of clinical study records, study data sets, and study data queries
• Project a mature, professional image and provide responsive, meaningful, high-quality clinical operations support and follow-up to client inquiries
• Coordinate and support the maintenance of daily clinical operations workplans and calendars that track important activities, milestones, and deadlines
• Travel (US and international) of ~40% - 60%
• Manage and 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 Practice Leader and Team Leaders
• Report to the Clinical Solutions Practice Leader

• Minimum 4 years successful professional or contract research clinical operations experience with leading biomedical industry firms
• Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
• Understanding of harmonized GCP standards, the medical device product development and approval process, HIPAA, 21CFR Part 11, the FDA Quality System Regulations, and ISO 13485 (2003)
• Comprehensive understanding of the medical device product development process
• Undergraduate BS or BA degree in nursing, an allied health profession, life sciences, or biomedical engineering from a leading university (Candidates with relevant clinical experience will be considered, depending upon experience.)
• Strong proficiency in Microsoft Windows and Office applications
• 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
• Must possess a valid driver's license and the ability to qualify for and maintain a corporate credit card with sufficient credit line to enable extensive business travel
• Must be willing to relocate to the Boston area permanently, for up to 2 years

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