Sr. Project Manager

• Jul 2022 - Present

Senior Clinical Project Manager

• Jul 2022 - Jul 2022

Plan, track and run all activity throughout the project lifecycle, including deliverables from all functional areas and vendors to the project scopeDevelop project plans, timelines and status reports and communicates with all applicable team members in and outside the organizationPromote effective partnership among cross-functional teams and provide day to day direction for core teamMeet with team members on a regular basis regarding project tasks to ensure project achievementsServe as primary project contact with clientsCraft project budgets, communicate deviations from budget projections and propose solutions for budget deviationsLead problem solving and resolution efforts. You will provide dedicated and creative recommendations on how to meet goals and handle identified risks and deviationsEnsure that work is conducted in compliance with professional standards and SOPs, and meet quality and timeline metricsBuild and maintain strong pharmaceutical industry sponsor and organizational team relationships for the success of clinical trial managementMentor project managersParticipate in proposal development, bid-defense process and presentations

Sr. Consultant Research Quality Assurance

• Sep 2019 - Jul 2022

Activities include a variety of complex and varied support functions including developing and managing the research education program, extensive quality assurance review across multiple complex studies through monitoring and auditing activities, establishing and implementing process improvement projects and developing and managing a policy, procedure and guidance program.• Assist with activities within the QA program for monitoring research projects that are not monitored via a Good Clinical Practice compliant monitoring plan and routinely audit all trials. • Work to establish and implement strategic goals for the quality assurance program. • Develop and maintain a monitoring and audit plan process and associated documents to accurately record findings. • Participate in protocol feasibility based on risk matrix and review of protocols for quality assurance input. • Maintain quality assurance and control metrics to track, trend and create/present reports provided to OHRI leadership. • Perform extensive QA review across multiple complex studies of different therapeutic areas and phases and report findings to management and research team. • Review and monitor the staff’s plan to resolve any action items.• Assist in risk assessments and the preparation of any reports. • Assist and maintain the policy, procedure and guidance program. • Monitor the compliance of institutional policies and procedures as related to research project quality assurance. • Author and train others on developing, submitting and updating standard operating procedures, guidances, and templates to ensure quality assurance. • Assist with the development and management of the OHRI education and training program. • Assist with the development and continuous improvement of the education and training program designed to promote adherence to policies and regulations for staff involved in human subject research.

Assistant Director Clinical Trials

• Jun 2016 - Apr 2018

- Hire, supervise, coach, mentor, and manage performance of the supervisory staff in the office and provide oversight of the staff who report to them.- Establish and maintain an organizational structure that optimally supports the conduct and support of clinical trials in the Center.- Support the UACC Director and Associate Director of Administration in driving unifying clinical development strategies across the two campuses, Tucson and Phoenix. - Support the Deputy Director of the UACC in the running of the UACC-Phoenix, including hiring, grants, space, and clinical trials.- Develop and maintain Clinical Trials Office policies, procedures, work instructions, and other resource information that allows the staff to perform efficiently and to deliver a high quality work product.- Oversee multiple areas within the UACC-Phoenix Clinical Trials Office, accountable for ensuring excellence and compliance in areas of human resources, clinical trials, grants/contracts management, public relations/communications, philanthropy, and facility management- Provide input to the development of annual budgets for the clinical trials operation, monitor financial status, and take appropriate actions required to manage to budget.- Provide information in support of the NCI Cancer Center Support Grant, progress reports, renewal applications, other grant applications, and contract proposals.- Maintain a high level of knowledge regarding clinical research protocol development and conduct, budgeting, and contracts in order to serve as a resource for the staff and investigators.- Provide oversight of regulatory compliance and monitoring.- Serve as an effective liaison for all UACC investigators with industry sponsors for potential clinical trial development and funding.- Work with the communications group to develop internal and external communications to develop positive and informative messaging for the UACC-Phoenix.

CTO Disease Team Leader

• Sep 2012 - Jun 2016

Clinical Research Manager to function as a CTO Disease Team Leader who will manage, develop and oversee the conduct of clinical trials of a cancer disease-specific research team within OSUCCC Clinical Trials Office (CTO) under direction of Administrative Director; oversees planning, organization, implementation and execution of all clinical research projects specific to disease team; manages and supervises daily administrative, operational, research and patient care activities in a specific cancer disease site collaborating and communicating with faculty, administration, research staff and shared resources within James Cancer Hospital and OSUCCC as appropriate; plans, directs, assigns and monitors team workflow, activities and productivity toensure fulfillment of research goals; assists Administrative Director in hiring, supervision, training, scheduling and evaluation of research personnel; directly manages own team of clinical research staff; develops and implements plans to meet requirements of new studies/protocols and ensures all requirements within disease team are met; plans and leads disease team meetings at whichprotocol activity and progress, resource allocations and productivity benchmarks are reviewed; provides feasibility assessments; conducts quality assurance reviews of research processes and data; collaborates with OSUCCC investigators and regulatory staff in the development, review, submission and implementation of research protocols; on a limited level, collaborates with PrincipalInvestigator to develop, negotiate, implement and administer research study budgets; reviews, monitors and approves expenditures to ensure appropriateness; manages and supervises recruitment, interviews, screening and enrolling of patients into research protocols; develops, implements and oversees education of patients participating in study; ensures appropriate patientcare and follow-up according to protocol; participates in writing and submission of manuscripts,

Multiple Myeloma Project Manager

• Jul 2010 - Sep 2012

- Functioning back-up to Clinical Research Manager.- Maintaining clinical research portfolio and all associated items for the Multiple Myeloma Disease team.- Assisting with writing manuscripts & articles for publication and presentation as well as data analysis- Verifying and maintaining high quality of clinical research coordination for our multiple myeloma clinical trials- Verifying and maintaining high data qualify of our clinical research data for our multiple myeloma clinical trials.- Maintaining a very close relationship with our multiple myeloma clinic team as well as our research team in order to bring the groups together and facilitate open communication and efficiency in our processes.- Communicating with all groups, internal and external, regarding any potential issues that arise with any of our multiple myeloma clinical research studies- Participating in many projects to help our clinical research team and management group including (but not limited to): OPAL Workload Scoring, Feasibility Surveys, Clinical Scientific Review Committee Submissions, Institutional Review Boards Submissions (Initial and Continuing), Metric Tracking for trial timelines, Celgene - Pomalidomide and Lenalidomide Training, DMAIC model application, Institutional Review Board Safety Reporting, Cancer & Leukemia Group B Training

Clinical Research Coordinator

• Apr 2008 - Jul 2010

Recruiting, interviewing and enrolling patients into clinical research studies.- Obtaining informed consent- Coordinating and documenting care of patients and ensuring proper follow up is scheduled and conducted in accordance with the protocol guidelines.- Providing physicians with study mandated criteria necessary for patient orders, response, complications, and to ensure protocol compliance.- Assisting physician to evaluate and grade toxicities- Communication with internal and external parties on protocol and patient status.- Assisting in developing plans to meet requirements of new protocols and implementing these protocols- Educating patients and their families of the purpose, processes and goals of clinical studies and answering questions regarding these studies.- Coordinating sample preparation, procurement, and delivery of clinical research specimens

Clinical Research Data Coordinator

• Aug 2007 - Apr 2008

- Managing the data entry, data quality, and case report form for multiple clinical research studies- Worked in collaboration with multiple individuals to ensure protocol compliance.- Managed clinical research charts.- Navigating medical center systems and databases.- Navigation of patient medical records.- Coordination with multiple departments throughout The Ohio State University to obtain necessary information to ensure complete data for multiple patients and multiple clinical research studies.