(US-Massachusetts-Boston) We are looking for an innovative and detail-oriented person to play a key roll in helping to further development and refinement of our core technology of precision thermal control. He or she must be capable of handling all aspects of the engineering process from concept through development and ongoing support. The ideal candidate will possess a BS or MS degree in a Mechanical Engineering discipline, and will have experience in analyzing thermal systems and design elements in machines or instruments (not HVAC). Thermal FEA experience is required, structural FEA is a big plus, as is experience using ProEngineer and optimizing closed-loop control systems. The candidate must also have a good working knowledge of material properties and common manufacturing processes for metals, ceramics and composites, and should be able to adapt established processes for novel applications.
(US-Pennsylvania) (3 openings) for our client, an international health and life sciences company. These are in-house positions requiring between 50-70% travel. Ideal candidates will conduct on-site monitoring visits to verify that the rights and well-being of human subjects are protected; that reported trial data are accurate, complete and verifiable from source documents; and that the trial is conducted in compliance with the currently approved protocol, with GCPs, ICH Guidelines and FDA regulations. Individuals are the main liaison between the site and our client and will perform pre-study visits to evaluate adequacy of site, investigator and research staff in accordance with Sponsor protocol, our client’s SOPs, GCPs, ICH Guidelines and FDA regulations. Candidates will ensure that study documentation is completely and properly maintained. Ideal candidates will also prepare and submit timely appropriate monitoring forms and site visit reports in accordance with the Project Operations Manual and our client’s SOPs. Candidates will also monitor Investigator compliance for the reporting of Adverse Events and Serious Adverse Events to our client and/or the Sponsor and the IRB. POSITION REQUIREMENTS Ideal candidates will hold a Bachelor’s Degree in a scientific discipline or equivalent applicable experience such as a Nursing Diploma. RN, CCRA or CCRC certification preferred. Specific experience with solid tumors and with chemotherapeutics is required. A minimum of 16 months of field monitoring experience is required. In depth working knowledge of GCPs, ICH Guidelines, FDA Regulations, the drug development process and company SOPs. Excellent interpersonal skills and communication are required to be successful in this role. Multi-therapeutic experience is required and there is a preference for Diabetes, Oncology and Cardiology. COMPENSATION Compensation is competitive with a base salary range between $55-$70K depending on experience. You will also be eligible for an annual bonus. The package includes comprehensive benefits as well as a friendly, casual, and energetic environment in which to work.
