Michelle Sanchez

• Built strong relationships with Sponsors through positive attitude and attentive response.
• Assisted in recruitment of new team members, hiring highest qualified to build team of top performers.
• Supervised team members to confirm compliance with set procedures and quality requirements.
• Established open and professional relationships with team members to achieve quick resolutions for various issues.
• Monitored team performance and provided constructive feedback to increase productivity and maintain quality standards.
• Conducted training and mentored team members to promote productivity, accuracy, and commitment to friendly service.
• Coached team members in techniques necessary to complete job tasks.
• Mentored and guided employees to foster proper completion of assigned duties.
• Communicate with Project Manager and/or Sponsor regarding operational deliverables on assigned studies
• Mentors and coach's new hires and supports onboarding activities
• Leads process improvement efforts and pilot's new processes
• Supporting the Manager, Site Services in operational leadership activities
• Participating in project meetings, and training calls Assists Project Managers in maintaining, reviewing and communicating project progress.
• Monitor processing of technical and logistical edit checks and outliers and assist other study team members as needed to maintain study deliverables
• Report metrics of operational deliverables on assigned studies to Manager, Site Services
• Participate in internal audits
• Train internal staff on study specific procedures
• Responding to inquiries in a professional, courteous and timely manner
• Responding to inquiries in a professional, courteous and timely manner Supports Site Services initiatives
• Provides training on operational processes and updates flowcharts and SOPs Maintains Quality Service and Departmental Standards
• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Serving as additional point of contact to client, sites, sponsors, etc.
• Keeping supervisor advised of current issues
• Communicating and following up on project tracking discrepancies
• Identifying site and data trends, and recommending actions to Project Manager
• Entering, maintaining, and tracking of data in internal software
• Planning, coordinating and leading the site start-up activities
• Reading and understanding project protocol documents
• Coordinate with clinical study teams, Bioclinica Clinical Project Managers and Clinical Data Managers for
• Managing site communication, including distribution of subject data reports Assisting in tracking and resolving of client issues

As the Imaging Research Associate II - coordinates all Medical Imaging services and operational activities, from study start to study close, to ensure the timely delivery of high-quality images service deliverables for assigned studies.

• Responsible for executing any/all of the functions that an Imaging Research Associate, performs
• Planning, coordinating and leading the site start-up activities
• Communicate with clinical sites regarding image quality, data discrepancies and changes in image collection procedures
• Participate in creation and distribution of clinical site training materials (i.e., study specific manuals, videos and translations) and sponsor/clinical site reports
• Provide technical site support (i.e., field clinical site questions pertaining to study related data, confirm site eligibility)
• Responding to inquiries in a professional, courteous and timely manner
• Coordinating machine change instances for appropriate documentation and equivalence data collection
• Responding to inquiries in a professional, courteous and timely manner Supports Site Services initiatives
• Scheduling and tracking completion of site training
• Assisting in monitoring data flow
• Generates, tracks and resolves data queries
• Planning, coordinating and leading the site start-up activities
• Ensure data is collected and maintained according to applicable SOPs and/or study protocol requirements

• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Prepare study-related documentation such as protocol worksheet, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Coordinate, supervise and document all study start-up through end of study activities involved with data processing and site management for assigned studies.
• Communicate with clinical sites regarding XRAY, MRI and/or CT image quality, data discrepancies and changes in image collection procedures.
• Communicate with Project Manager and/or Sponsor regarding operational deliverables on assigned studies. Experience ranging from expedited start-up to close-out study phases of Phase II/III Clinical Trials of MSK neurology (Alzheimer Disease), /CNS, and oncology clinical trials.
• Organized, monitored, implemented, and reported clinical study progress to the clinical management team as required and created and maintained patient, study and regulatory files and status reports.

• Process clinical data including receipt, entry, verification, or filing of information.
• Assist clinical operations associate with providing technical site support (i.e., field clinical site questions pertaining to image data, confirm site eligibility)
• Generate queries (i.e. data clarifications, incomplete package notifications, repeat request notifications) for resolution with clinical sites.
• Perform data entry, loading and labeling of digital images (e.g. CT, PET, MRI).
• Review, process, track and monitor all image data received from clinical sites.
• Reviewing data received; verifying data transmittal form is complete and accurate and appropriate media is enclosed.