Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSCSM1

Position Description

This position is full-time (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
• Coordinate study monitoring activities by interfacing with clinical investigators and study site personnel
• Conduct and manage study site qualification visits to ensure the adequacy of Site Investigator qualifications and resources
• Interface with clinical investigators and study site personnel to determine compliance with protocol and regulatory requirements
• Conduct and manage study site initiation, monitoring, and close-out visits
• Conduct and/or manage Site Investigator and study personnel training to verify that all study personnel are provided with the necessary instruction to properly use, handle, store, and return the investigational product(s)
• Manage the receipt, use, and return of the investigational product(s) at the study sites(s) (verify the adequacy of all storage, accountability and maintenance practices)
• Verify that the Site Investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the study
• Monitor the accuracy and completeness of the Case Report Form entries, source documents, and other study-related records
• Support the generation and resolution of clinical study data queries
• Determine whether all adverse experiences are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Institutional Review Board (IRB)/ Research Ethics Board (REB), the Sponsor, and the applicable regulatory requirements
• Verify that the Site Investigator is maintaining the essential documents for the conduct of a clinical study
• Project a mature, professional image and provide responsive, meaningful, high-quality clinical operations support and follow-up to client and study site inquiries
• Assist the Clinical Solutions Practice with the maintenance of daily clinical operations workplans and calendars that track important activities, milestones, and deadlines
• Travel (US and international) of ~40% - 60%
• Retrieve and manage the maintenance of study site documents
• 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 senior management
• Report to the Clinical Solutions Practice Leader

• Minimum 3 years successful professional or contract research clinical operations experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research industries (Entry level candidates will be considered, depending upon experience.)
• Fluency in harmonized GCP standards, the medical device product development and approval process, HIPAA, 21CFR Part 11, the FDA Quality System Regulations, and ISO 13485 (2003)
• Strong, documented proficiencies in Good Clinical Practices and related Standard Operating Procedures
• Comprehensive understanding of the medical product development process
• Successful, significant contributions to Class II and III regulatory submissions and approvals
• Documented, contemporary training and ACRP/OCRA certifications in Clinical Research, Clinical Study Monitoring, or Quality Auditing
• 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.)
• Certifications in Clinical Research, Clinical Study Monitoring, or Microsoft Windows and Office applications preferred
• Must be willing to relocate to the Boston area permanently, for up to 2 years
• 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

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