Michael Marotta Email & Phone Number

Strongsville, OH, US

• The Project Manager assumes a leadership role within the study team by supervising and facilitating the planning, conduct, and closeout of clinical trials with study sponsors. The Project Manager acts as the primary.
• Ensuring client’s clinical studies are conducted with high quality, on schedule, and within budget
• Collaborating with clients to built project plans establish deliverables, timelines, and budgets
• Managing project timelines to meet project milestones
• Developing project, monitoring, communication, risk management, and other study plans as applicable
• Coordinating and overseeing activities of monitoring, data management, biostatistics and other areas as needed to accomplish study milestones

• Part of the management team responsible for supporting the monitoring department through supervising, training, and hiring CRAs.Responsibilities included:
• Supervising CRAs to ensure duties are carried out as assigned
• Completing CRA evaluation monitoring visits
• Preparing and delivering bi-annual performance evaluations for internal CRAs
• Evaluating new projects and make CRA assignments
• Participating in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, FDA regulations, and other applicable regulations

• Project Management Responsibilities included:
• Managing monitoring projects, supervising project-specific requirements and activity and working with the Project Manager and/or client to ensure study objectives were met.
• Coordinating training of the monitoring team on the study protocol, therapeutic area, and investigational product
• Developing and updating monitoring plans as needed
• Assisting with the development of study documents, monitoring checklists, etc. when necessary
• Coordinating activities of the monitoring team to ensure compliance with overall study objectives

• Responsibilities included:
• Conducting site assessment, site initiation, periodic site visits, and close out visits and writing reports of findings from site visits
• Conducting remote review of electronic data, identifying and following up on discrepancies, and performing on-site source data verification
• Assisting sites with regulatory documentation, and ensuring appropriate documents are sent to the sponsor
• Identifying and following up on compliance issues
• Training research coordinators and physicians on study protocols and federal regulations/requirements related to clinical studies

Cleveland, Ohio, US

• We have generated a large haplotype map to identify potential recombinant hotspots that serve as a risk assessment for ERBB2 amplification, a subset and particularly virulent form of Breast Cancer. (Lead researcher)
• To perform a genome wide analysis of amplified and non-amplified breast tumors in order to determine the role of palindrome formation on gene amplification. (Lead Researcher)
• Using Next Generation Sequencing, genomic, and cytogenetic approaches to define the formation of a commonly amplified region in cancer, 1q21. (Lead researcher)
• The biological requirement and function of Mre11 on double strand break repair and cell cycle control. (Secondary researcher)
• The role of non-coding RNA on replication fork stalling and how fork stalling can lead to DNA instability and rearrangement. (Secondary researcher)

Cleveland, Ohio, US

• Development of a lethal mutagenesis protocol as a novel antiviral strategy against HIV-1. (Lead researcher)
• Screening/evaluation of novel anti-HIV-1 compounds for potential therapeutic use. (Lead researcher)
• Establishing a quantifiable protocol to monitor HIV-1 fitness. (Secondary researcher)
• The role of Human Beta Defensins as an anti-HIV-1 agent. (Secondary researcher)

University Heights, OH, US

Graduate Assistant in the Biology Department at John Carroll University

Ms, Biology

Bs, Biology