Serve as the single point of contact for team members and Core Lab personnel to ensure consistency across studies for Core Lab-adjudicated data collection and reporting. Provide study support and leadership of Core Lab vendors and data from study start-up through closure. Responsible for the quality, accuracy and timeliness of Core Lab data in accordance with study agreements and protocols.

Assists with the execution of clinical research projects, in accordance with applicable regulatory requirements and company policy. Coordinates the administrative and logistical aspects of clinical studies and oversees adherence of the investigational sites to the Investigational Plan/Study Protocols.Key Roles:- Oversee investigational site compliance with study protocols and implement CAPA as needed- Manage multiple Core Laboratories for post-market studies- Perform remote monitoring for post-market studies to verify accuracy of data entry- Conduct site initiation visits- Develop tools to assist sites in fulfilling protocol requirements- Assist with study database management activities- Assist with auditing study files

Assists with execution of clinical research projects, in accordance with applicable regulatory requirements and Company policy. Coordinates the administrative and logisticalaspects of clinical studies and oversees adherence of the investigational sites to the Investigational Plan/Study Protocols.Key Accomplishments:- Participated in FDA BIMO audit of study sponsor; assisted in preparations of Core Laboratory for FDA BIMO audit- Provided critical data for PMA submission for IDE study, including protocol deviations and adverse events- Oversaw compliance of the investigational sites with clinical study protocols and implement corrective and preventive measures- Prepared and reviewed Protocol Deviation reports, identified non-compliance, documented efforts to secure protocol compliance at investigational sites, including CAPA- Conducted Protocol Deviation review meetings (internal and with the site personnel)- Developed tools to assist with study compliance initiatives- Managed Angiographic Core Lab personnel dedicated to the CSI clinical studies- Assisted with study database management activities- Assisted with auditing study files

Program Director - Responsible for oversight of all aspects of an AAALAC-accredited animal care and use program, including IACUC operations, regulatory compliance, budget development/management, research client services, animal husbandry, veterinary care, and physical plant design and processes.Key Accomplishments:- Authored key reports and documents for timely and accurate submission to federal and accreditation agencies to maintain critical licensing and external funding requirements- Maintained compliance with federal, state and other regulatory agencies by keeping pace with changes in standards and best practices- Created a limited CRO within the organization to provide outside sources of revenue; cash receipts generated by CRO activities reached totals of up to $320+K per year- Instituted a team approach for animal care staff to consolidate tasks and increase flexibility to meet the fluid needs of the research staff- Wrote multiple documents, including Program Descriptions, meeting minutes, SOPs, policies, training materials, and safety guidelines; many of these were recognized by internal and external reviewers for their attention to detail and clarity

Manager, Animal Care and Use program. Served as the Attending veterinarian on the IACUC, managed the vivarium and animal care staff, submitted reports to regulatory agencies, and continued to refine and improve the animal care and use program. Key accomplishments:- Designed a 3600 square foot rodent housing and procedural area that incorporated design inputs from investigators, animal care staff, and construction experts to create a flexible, functional space- Submitted and managed multiple budgets totaling up to $500K per year; handled both capital and non-capital acquisitions- Created relational databases for IACUC administrative processes to be used for maintaining regulatory compliance, conducting internal audits, and building reports

Manager, Animal vivarium and clinical veterinarian. Developed multiple processes and produres for the animal care and use program for the purpose of bringing the organization into compliance with AAALAC standards. Among the new processes introduced or refined include development of standard operating procedures, recordkeeping and documentation standards, tracking procedures, and standardized post-operative care.

Provided surgical support for research projects involving microsurgery on animal models, including renal transplants, aortic grafts, liver transplants and ophthalmic procedures. Processed and analyzed histologic sections from transplanted organs. Trained surgical residents in microsurgical techniques.