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 contact for study issues from the study sponsor and internal team, ensures team training and study updates, and communicates appropriately. The Project Manager will oversee the study timeline to ensure milestones are achieved and deliverables completed in a timely manner. Further, the Project Manager is responsible for ensuring study activities are conducted within the project budget.Responsibilities may include, but are not limited to, the following:•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•Ensuring study compliance with clients and sites•Organizing and directing study team activities•Providing and/or coordinating site and study team training, including development of training materials•Development of study documents, checklists, and trackers•Supervising project-specific field monitoring activities•Managing study subcontractor activities•Providing timely communication with site/study teams•Making recommendations on inclusion of sites to clients

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•Participating in the selection process of new hires, including reviewing candidates’ credentials, interviewing candidates, and making hiring recommendations•Maintaining professional skills by keeping abreast of literature, attending conferences, courses, and meetings•Maintaining knowledge of regulations, guidelines, policies, and practices for conducting (global/international) clinical trials•Identifying nonconformances, suggest improvement opportunities and suggest preventative actions when potential nonconformances are identified

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•Reviewing study documents and/or electronic databases to monitor enrollment and ensure site visits are being conducted as needed•Tracking any site/patient related issues as necessary; reporting significant findings to the sponsor •Acting as the primary contact for all monitor related questions for the team•Interacting on behalf of the monitoring team to the client•Setting up, attending, and maintaining minutes for study-related conference calls and minutes•Ensuring monitoring tools were generated, finalized, and maintained•Making recommendations on inclusion of sites to clients•Providing training during Sponsor meetings•Providing feedback to management for CRA performanceCRA Support Responsibilities Included:•Facilitating consistent and timely communication between Sponsor and assigned CRAs•Reviewing various types of monitoring reports autonomously, utilizing multiple templates, making edits and providing feedback as necessary•Supporting CRAs in handling difficult/challenging situations•Assisting CRAs in formulating corrective actions related to site compliance•Collecting updates and representing CRAs on monitoring calls as needed•Serving as a back-up to the CRA team, conducting visits as needed•Conducting co-visits and providing performance feedback•Assisting in CRA orientations and/or ongoing CRA training•Escalating non-compliance according to IMARC/sponsor SOPs

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•Providing support and assistance to clinical research sites•Acting as a liaison between sites and the sponsor and CRO

• 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)

• 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)

Graduate Assistant in the Biology Department at John Carroll University