Development of clinical protocols with statistical justifications, data analysis, patient informed consent, data collection forms, clinical site study material, and clinical databasesAssist with regulatory submissions including 510(k), PMA, IDE and othersOversee initiation and implementation of clinical investigationsDevelop and maintain project timelines and study budgets Coordinate physician meetings such as Investigator Meetings, Clinical Events Committees, and Data Safety Monitoring Boards. Internally interface with data management and biostatistics, field clinical monitors, senior management. Review clinical publicationsCoordinate clinical site audit activities including pre-inspection training at clinical sites and within the department.Work under the direction of management on complex problems where analysis of situations or data rquires an in-depth evaluation of various factors. Support program management for project reviewsInterface with interdisciplinary team (Regulatory, Quality, R&D, Safety, Marketing, Biostats and Data Management), physicians/KOLs, and other study support personnelMonitor and audit clinical data and clinical sitesFollow U.S. FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards, clinical investigations, monitoring procedures and medical device reporting.

Development of clinical protocols with statistical justifications, data analysis, patient informed consent, data collection forms, clinical site study material, and clinical databasesAssist with regulatory submissions including 510(k), PMA, IDE and othersContract negotiationSupport program management for project reviewsDevelop and monitor study budget and project timeline, develop project management tools and provide project updates and presentationsResponsible for managing CROs, imaging core labs, IVRS/IWRS and other vendorsInterface with interdisciplinary team (Regulatory, Quality, R&D, Safety, Marketing, Biostats and Data Management), physicians/KOLs, and other study support personnelOversee device supply and distribution and provide guidance on product supply processReview and approve clinical monitoring reportsFollow U.S. FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards, clinical investigations, monitoring procedures and medical device reportingDevelop operating procedures for clinical investigations

Assist with regulatory submissions including 510(k), PMA, IDE and othersInitiation and implementation of clinical investigationsAssist with development of clinical protocols with statistical justifications, data analysis, patient informed consent, data collection forms, clinical site study material, and clinical databasesAssist in managing CROs, imaging core labs, IVRS/IWRS and other vendorsManage device supply and distribution and provide guidance on product supply processConduct site visits and study training Maintain contact and provide site support during studyReview clinical monitoring reportsInterface with physicians and study support personnelFollow U.S. FDA and international regulations pertaining to medical devices and industry guidelines related to regulatory submissions, institutional review boards, clinical investigations, monitoring procedures and medical device reportingMonitor and audit clinical data, clinical sites, and study related activitiesDevelop operating procedures for clinical investigations

Support Management with day-to-day activities pertaining to clinical trials conducted for new product license applicationsDevelop various forms/templates, including the informed consent/assent master template and its local versions, CRFs, study newsletters, and any other study specific formsAssist in vendor set-up and management of vendors (including clinical CROs)Primary contact for coordination of protocol questions from CRAs and study sitesReview essential documents from study sites for accuracy and completion including site informed consentProvide guidance in the product supply processConduct co-monitoring visits to check performance of field CRAs

Provide biobank management support for about 30 studies and serve as subject expert for biomarker developmentResponsible for laboratory vendor selection, evaluation of lab spec worksheet, scope of work and laboratory manuals and liaise between Molecular Sciences scientists, clinical team, core and specialty laboratories and other functional teamParticipate in writing of clinical protocols and development of study specific Informed Consent Form template Review country and site specific subject informed consent forms for multiple global-mega studiesPrepare study reports for weekly teleconferences with central lab vendor and updates tracking systems for outstanding queries and sample order requestsProvide training to clinical teams on sample ordering mechanism and central lab web-based sample management toolsInterface with a multi-faceted clinical project team (clinical study team, biostatistics, data management, clinical monitors, and regulatory associates) to achieve successful clinical studies within appropriate timeframes

Provide oversight and delegate duties for efficient site operation and report directly to the CEO and the President of the companyHire, train, supervise, motivate, review, and when necessary, terminate employeesManage site Clinical Research Coordinators in coordinating pharmaceutical trials ranging from Phase I to IV, ensuring compliance with the CFR, GCP and all internal SOPs and guidelinesManage pre-study and site initiation planning, including investigator meetings and clinical site recruitment including evaluation of site feasibility and study budget for potential studiesConduct internal site monitoring, which includes routine source data/document verification to ensure accuracy, thoroughness, regulatory compliance and resolution of data queriesMonitor all safety issues and continuous site evaluation by communicating project progress, challenges, and opportunities on a regular basis to sponsoring companiesOversee delivery, shipment, inventory and accountability of investigational products and equipment to conduct clinical investigationsRecommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes. Develop and implement study specific versions.Participate in the development and implementation of site specific marketing and patient recruitment plans

Assist in designing and developing research protocols Recruit, assess, and retain subjects to various research projects such as risk assessment of hypertension and effects of nicotine on ADHD Collect psychological, family history, and physiological data and medical sample Process and conduct statistical analysis of research data