Denise Parisano

NA

• Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
• Prepared and submitted regulatory file applications and supporting documentation.
• Participate in study team meetings and ongoing protocol training/compliance meetings.

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Followed informed consent processes and maintained records.
• Collect , review and report study data, complete case report forms and resolve data queries.

• Coordinate the conduct of Phase 1-1V Clinical trials for the Center for Rare Cancers and Personalized Therapeutics.
• Assist in the coordination of 5-6 pharmaceutical research trials including: start-up and close out, documentation of serious adverse events.
• Develop/maintain regulatory binder's and all research supporting documents
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Followed informed consent processes and maintained records.
• Maintain data utilizing several electronic databases including RAVE,InForm,Globalview,Medrio, Virtual Scopics and CITI certification, Velos, EPIC and Navicare.
• Gathered, processed and shipped lab specimens.
• Collected, evaluated and modeled collected data.

• To assist Clinical Project Managers in providing clinical direction for all trial components including Data Management,supplier selection/management and coordination of all the participants-sponsors-contract consultants.
• Planned, executed and controlled assigned projects, ensuring work performed complied with contractual requirements.
• Closely collaborated with project members to identify and quickly address problems.
• Performed independent analysis and provided recommendations to overcome project obstacles.
• Trial Master File Management(including eTMF) ; responsible for set-up, submission and maintenance of paper and electronic TMF. More than 10 years of eTMF experience involved in multiple studies.

• Resolved issues quickly to maintain productivity goals.
• Managed continuous improvement initiatives to drive gains in quality, flow and output.
• Reviewed work for quality and compliance with company standards and design specifications.
• Standardized production procedures, job roles and quality assurance guidelines.
• Responsible for planning implementation and management of single and cross-offering projects, which would include, but not limited to:
• Global Site Feasibility
• Patient Recruitment
• Activation and INDSR
• Rater Training
• Site Training
• SDE(Secure Document Exchange)
• Establish excellent working relationships with client project teams to ensure client satisfaction and operational excellence
• Prepare project status reports and metrics keeping management, customers and stakeholders informed of project status related issues.
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• Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
• Prepared and submitted regulatory file applications and supporting documentation for all Central IRB's.
• Wrote or updated standard operating procedures, work instructions or policies.
• Received, researched and resolved consumer inquiries.
• Process regulatory documents using electronic system,Secure Document Exchange (SDE) to expedite site turnaround.
• Responsible for the management of site start-up activities for studies using SDE including inform consent review and IRB?EC submissions.

• Facilitate the collection and approval and tracking of regulatory documents for all clinical studies.
• Review all site regulatory documents including informed consent forms for all studies to ensure completeness and accuracy.
• Ensure all required regulatory documents be obtained from all sites.