Buisness Area: Clinical Solutions

Location: Natick, MA

Position Code: CSSSU2

Position Description

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

• Successfully support the Clinical Solutions Practice Team 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
• Interface with clinical investigators and study site personnel to determine adequate qualifications, credentials, resources, and experience in the intended therapeutic area
• Support the Clinical Team with study site qualification visit preparation including review and/or negotiation of regulatory documents, budgets, and contracts
• Support the Clinical Team with compilation, organization, maintenance and production of all critical trial documents (IRB submission packages, Investigator Agreements, regulatory correspondence)
• 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
• Support the Clinical Team with preparation, and presentations for essential trial meetings (trial preparation meetings, investigator meetings)
• Interface with and provide progress reports to clinical monitoring, and program management staff
• Assist the Clinical Team in evaluating Investigator and site performance at closeout (e.g., Preferred Sites, Contact Clinical) to facilitate future site identification activities
• 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/or members of the Clinical Team
• Report to the Clinical Solutions Practice Leader

• Minimum 3 years successful professional experience with leading biomedical industry firms in the medical device, pharmaceutical, and/or contract research or related industries (Entry level candidates will be considered, depending upon experience.)
• Fluency in harmonized GCP standards, the medical device product development and approval process
• Documented, contemporary training and ACRP/OCRA certifications in Clinical Research, or Clinical Study Monitoring
• 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, required
• 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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