Megan Morash Email & Phone Number

Boston, Massachusetts, United States

Boston, Massachusetts, United States

• Oversee and perform review of research assigned to designated review chairs. • Provide resource for regulatory issues and institutional policies and procedures.• Develop and update standard operating procedures to improve efficiency, effectiveness and regulatory compliance.• Develop and present educational materials for researchers and presentations to research community.• Manage performance standards and conduct annual performance evaluations.• Represent the Partners Human Research Committee in meetings and serve on institution-wide committees• Interact with regulatory agencies as needed on matters related to institutional policies and procedures and regulatory compliance • Provide leadership for staff, including the building and maintaining of a stable work environment.

Boston, Ma

• Regulatory Compliance and Documentation: Ensured compliance with regulatory guidelines for investigator-initiated, sponsor-initiated, and other clinical research studies, overseeing all aspects of regulatory submissions and documentation.• Streamlined IRB Approval Process: Successfully tracked each research protocol through the IRB/subcommittee approval process, proactively identifying recurrent issues and implementing efficient systems to minimize approval process delays.• Informed Consent Expertise: Actively participated in the creation and review of informed consents, collaborating with legal and sponsors to ensure Clinical Trial Agreement (CTA) language was in harmony with consent documents.• Effective Stakeholder Interaction: Demonstrated strong interpersonal skills, collaborating seamlessly with a diverse array of stakeholders, including investigators, clinical research coordinators, administrative staff, cooperative groups, clinical research organizations, IRB, other institutions, and pharmaceutical companies.• Sponsor Collaboration: Worked closely with sponsors to secure approval for all essential regulatory documents, ensuring that documents, access to Case Report Forms (CRF) and databases, and monitoring/auditing requirements were in place before study initiation.• Comprehensive Regulatory Management: Maintained electronic regulatory binders with all required documents, ensuring that the dedicated electronic study folder remained current and accurate..

Boston, Ma

 Managed multiple device research studies related to cardiovascular, respiratory, oncology and women’s health diseases. Executed marketing and recruitment of patients. Designed and executed clinical studies in accordance with GCPs, SOPs, and FDA regulations. Performed budget preparation and management for research trials. Prepared protocols, progress reports and grant applications for the projects. Prepared tables, charts, and slides for national professional meeting presentations. Designed and implemented databases to retain data from studies. Supported physicians during procedures by providing knowledge and expertise of the new medical treatment and device.  Provided nursing assessments for patient follow-up visits. Served as communication liaison between physician-investigators, industry representatives, and regulatory personnel. Provided patient education regarding new medical treatment.

Bachelor Of Science, Nursing

Education record

Master'S Degree, Organizational Leadership