Pulmonary Function Technologist

JOB # 3021197Smith Hanley Consulting Group (www.shcgpharm.com) has an excellent growth opportunity for a Pulmonary Function Technologist in NJ Job Description: Pulmonary Function Technologist Summary: -The Pulmonary Function Technologist will conduct pulmonary laboratory training as needed; assist with quality control and pulmonary test review audits; and participate in the training activities of contracted PFL trainers as requested by the Pulmonary Function Testing Supervisor. -The technologist will actively pursue and participate in the established professional growth program. -Additional daily activities include supporting ongoing coordination with contract research organization personnel (CROs), consultants, contractors, and other colleagues in Clinical Operations, Clinical Pharmacology, Medical Affairs, Biostatistics, Data Management and Regulatory Affairs. -All work performed by the Pulmonary Function Technologist will be under the direct supervision of the Pulmonary Function Testing Supervisor.  -The technologist is responsible for ensuring pulmonary program quality and consistency of performance in assigned areas. -In conjunction with other clinical colleagues, the Pulmonary Function Technologist is responsible for adherence to the overall drug development plan timeline as directed by the Pulmonary Function Testing Supervisor.  -At times, business necessary travel will be required and is estimated to be approximately 30% per calendar year. 1)  PRIMARY JOB RESPONSIBILITIES AND ACCOUNTABILITIES Under the direction of the Pulmonary Function Testing Supervisor, the Pulmonary Function Technologist will assist with aligning technical group efforts with Clinical Operations objectives as directed to meet clinical trial needs. The Pulmonary Function Technologist will be responsible for providing initial and ongoing testing technical training; electronic data transfer training, training for adherence to quality control requirements, providing test reporting instruction, and ensuring compliance with established policies and procedures regarding test performance, documentation control, and quality assurance. Relevant activities include, but are not limited to the following: a.) Actively participate in  the development and maintenance of timelines for clinical trial pulmonary testing support b.) Coordinate laboratory identification efforts to meet departmental geographical and timing objectives as directed by the Pulmonary Function Testing Supervisor c.) Providing pulmonary laboratory on-site training and system verification as directed by the Pulmonary Function Testing Supervisor d.) Assist with clinical trial pulmonary budgets and oversee contract generation as requested e.) Participate in  the development and completion of trial files, documents and materials (Laboratory quality control documents, Testing Logs, Equipment Maintenance and Troubleshooting Logs, and query generation / resolution) f.) Identify pulmonary vendors for trial support, equipment, and supplies as directed by the Pulmonary Function Testing Supervisor g.) Assist in preparations for Investigator Meetings and contribute to trial specific instructional manuals as directed by the Pulmonary Function Testing Supervisor h.) Actively participate in the planned professional development program i.) Assist with pulmonary budget utilization and oversight as requested by the Pulmonary Function Testing Supervisor j.) Develop and maintain project reports per trial as requested k.) Provide support for the Clinical Team / CRO team meetings from start up to completion of assigned clinical trials l.) Provide support for GCP audits during trial as requested to ensure quality and adherence to ICH GCP/ FDA / SOPs as requested by the Pulmonary Function Testing Supervisor m.) Ensure maintenance of accurate, current, and timely distribution of trial reports to the Pulmonary Function Testing Supervisor n.) Inform the Pulmonary Function Testing Supervisor of lapses in general coordination between functional areas, equipment or training difficulties, or possible laboratory compliance issues in a timely manner to predict potential lapses and provide proposals for resolve prior to a negative event. o.) Assist the Pulmonary Function Testing Supervisor in performing audits of pulmonary test reviews and report findings to the Pulmonary Function Testing Supervisor p.) Assist the Pulmonary Function Testing Supervisor in performing audits of the pulmonary function laboratory quality control activities and report findings to the Pulmonary Function Testing Supervisor q.) Provide on-site training and equipment certification as needed to meet project timelines r.) Assist with the development of and implementation of a training program to ensure the highest quality standards and enhance the training abilities of all pulmonary laboratory trainers Education/Experience: -The Pulmonary Function Technologist must be familiar with clinical research methodology and have adequate pulmonary knowledge to assist in pulmonary laboratory identification, contracting, and clinical trial support.  -In addition, the Pulmonary Function Technologist will have demonstrated expertise in pulmonary function testing, training, and troubleshooting abilities. -The Pulmonary Function Technologist must be a Registered Pulmonary Function Technologist (RPFT) with the National Board for Respiratory Care (NBRC) and be a licensed respiratory care practitioner (RCP). -The technologist must be a graduate of an approved respiratory care program and a 4-year undergraduate degree in respiratory therapy or related medical sciences is preferred. -The technologist must have the ability to perform pulmonary function testing on a variety of equipment models. -The demonstrated ability to successfully participate in groups and work with various levels of  colleagues involved in coordinating and executing clinical research are crucial. -Likewise, the ability to work on a team in a matrix management environment is essential for success in this position.  This position offers a great benefits package, compensation plan and relocation assistance!!  Qualified candidates will be given immediate consideration – please email resumes to: Jennifer Alexandrowicz at 800-684-9921 ext 266 or email jalexandrowicz@smithhanley.com  Not interested in this opening but know someone who is? Smith Hanley Consulting Group does offer up to $2,500 for referrals! Call me for details! 1-800-684-9921 ext 266. Education:Bachelor's Degree Reference Code:3021197