Michelle G Tobin Email & Phone Number

Midwest/ Northeastern United States Region

Coordination and management of clinical trials for Emphysema. Collaborates with an interdisciplinary team to coordinate all activities required to initiate and complete a clinical program. Participates in development, organization, implementation and completion of clinical studies according to FDA standards and Good Clinical Practice (GCP). Provides technical training and monitoring; coordinates daily activities of trial sites; assists sites on planning and implementing subject recruitment activities.•Evaluation and follow-up of clinical investigative sites: facilities, personnel, subject referral base, site’s experience with clinical studies and adherence to GCP.•Educates and assists sites to ensure timely subject screening and enrollment•Assessment of complications and serious adverse events. Including reviewing and reconciling data and documentation related to the event.•Conducts quality control to ensure compliance to the study protocol, trial material storage and accountability.•Supports IRB submissions, addendums and renewals.•Provides technical support and training to clinical investigators and their staff in regards to device trial information, the protocol, clinical and regulatory requirements and device implant support.•Contributes to the submission of clinical data and study reports to support regulatory submissions.•Assists in evaluation and analysis of clinical data.

Cleveland/Akron, Ohio Area

Expanding my knowledge through reading articles on clinical studies, FDA updates, cardiology, diabetes, stroke, neurology. Taking CME courses and exploring advancing my nursing degree.I also subcontract for a CRO as needed.

Northeast Ohio, Western Pennsylvania

Performed after market and clinical implants, follow-up testing and troubleshooting of implantable pacemakers, defibrillators and cardiac resynchronization devices. Traveled to provide expertise to other regions. Coordinated, prepared and presented educational in-services to HCP. Coordinated and supported post market studies.• Provided implant and follow-up support. Budgeted time for supporting sales representatives to enhance profitability and increase sales and revenues. Territory had 6th highest income in 2012.• Acquired and developed account in western PA to a quarter million in revenue in pacers only.• Scheduled educational topics monthly to key group of HCPs, providing knowledge and comfort with products which strengthened market share.• Collaborated with clinical department identifying 2 clinical sites which included collecting data and reinforcing training.

See description under Clinical Engineer Supervisor

Collaborated with clinical department identifying clinical sites; presented study protocol; provided education, technical implant, follow-up support and data collection until closure of IDE or post market study. Assisted sponsors with IRB submissions and co-designed CRFs. Decisive on-going monitoring of clinical data and validation for studies that were not in given region.• Improved education and training for new FCEs, sales representatives and support team. • Recruited, interviewed and advised on hiring of FCEs and technical sales representatives, supervised roles to include training, time management, and goal setting.• Formulated and collected monthly data, utilized information in reviews to reflect bonus programs.• Initiated and closed 12 IDE studies without major violation.• Monitored and prepared for FDA audits for 5 studies. Supervised (sponsor unavailable) an FDA audit and facilitated requirements without any major violation.• Trained more than 30 new and employees, recorded and managed progress.• Supported and directed 8 fellow employees (maximum staff).• Prepared and presented clinical and released product presentations to in-house national meetings and to HCP sites.

Cleveland, Ohio

Participated and supervised testing, programming, monitoring and troubleshooting in relation to all patient procedures correlating with diagnosis and symptoms, which included reconciliation to pre-procedural checklist. Established lab’s SOPs in accordance to OSHA regulations. Staffed and supervised lab team, organized and budgeted supplies and established collaborative relationships with vendors. Participated in vendor clinical trials – collection and documentation of data; as well as individual research trials to submit educational abstracts to national meetings.

Cleveland, Ohio

Cleveland, Ohio

Cardiac Unit, Step down and ICU