Description
POSITION SUMMARY: Assist in preparation of clinical protocols and FDA submissions. Perform site initiation and close-out visit, reviews and audit data collection forms, participate in Investigator Meetings, assist in physician training, train site research coordinators, develop study guides and SOPs, resolve queries, support animal lab work, assist investigational sites with ethics committee submissions, attend team meetings, and work with core lab and safety committees. Coordinate physicians meetings such as Investigator Meetings, Clinical Events Committees, and Data Safety Monitoring Boards. Assist with routine Clinical Data Processing activities as required.PRINCIPAL ACCOUNTABILITIES: Assist with regulatory submissions including 510(k), PMA, IDE, and others. Assist in the initiation and implementation od clinical investigations. Assist in the development of clinical protocols with statistical justifications, data analysis, patient informed consent, data collection forms, clinical site study material, and clinical databases. Conduct pre-investigational site visits and staff in-service. Maintain contact and support during study. Review and approve clinical monitoring reports. Interface with physicians and study support personnel. Review clinical publications
EXPERIENCE: Clinical study experience in medical device of pharmaceutical field. Working knowledge of Good Clinical Practice (GCP) guidelines. Advanced reading and math. Excellent written and verbal communication skills Computer literate; word processing, spreadsheet, database, presentations, graphics. Clinical monitoring procedures. Recognize problems and take corrective measures. ISO 9000, EN 46000, Medical Device Directive (EC), Code of Federal Regulations (U.S)
EDUCATION: Bachelors degree in biological or health sciences. Training relative to Company requirements and procedures and individual job duties will be provided. A training file containing documentation of all training received is maintained for each employee.