Katherine Simpson Email & Phone Number

Remote

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. We bring together approximately 25,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are Shortening the distance from lab to life®, visit syneoshealth.com.

New York, Ny

I currently manage the Protocol Activation Core, a centralized unit at MSK that processes all clinical trials through the review and approval space at MSK. We are the "party planners" of protocol activation, coordinating with numerous units - Finance, Contracts, Operations, IT, Clinical Trials Nursing, among others- ensuring rapid activation of clinical trials. The goal is to get clinical trials to our patients faster, while maintaining quality of research and focusing on our customers.My team has grown over the past 3 years and is now over 35 people (and still growing!). Process improvement and streamlining the research space at MSK is my favorite part of the job. I create and setup processes, policies, and workflows. I strive to maintain transparency, and to always be there for my staff.

New York, Ny

I made the transition out of the Clinical Trials Office into the centralized Office of Clinical Research, providing operational and management support to many services that did not have the traditional clinical research staffing model. I worked with so many services I had to come with an acronym – A-LMNOP: Anesthesiology, Lab Medicine, Nursing, Office of the Physician in Chief, and Pathology. About a year into the role I was asked to also oversee CHERP, the Cancer Health Equity Research Program, where I helped operationalize clinical trials and open them at MSK to some of the Health & Hospitals locations in the NYC boroughs.

405 Lexington Avenue

Department of Pediatrics, Clinical Trials Office•Managed four independent medical oncology research programs: Developmental Therapeutics, Neuroblastoma, Leukemia and Lymphoma, and the POETIC consortium•Led and supervised the Data and Coordinating Center of the POETIC national consortium—a 10-institution early phase trial consortium for pediatric/adolescent patients with cancer and related disorders•Ongoing design, development and implementation of more than 60 Phase I-III clinical trials according to the interests of 12 attending physicians•Project management of all trials inclusive of study activation, initiation, on-study and close-out activities•Performed quality assurance and compliance checks, through both real-time monitoring and auditing •Developed budgets and managed contracts•Responsible for protocol compliance control, accomplished through staff education and training at MSKCC and participating POETIC sites utilizing on-site and web-enabled remote access•Created Standard Operating Procedures to ensure compliance to internal and external standards and to streamline performance for both the Department of Pediatrics and the POETIC consortium•Performed regular extensive reviews of informed consent forms for all initial and protocol amendments for MSKCC and all participating POETIC sites

405 Lexington Ave

Department of Pediatrics, Clinical Trials OfficePediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC)•Managed overall operations for the Data and Coordinating Center for the POETIC consortium (10 sites) and all collaborating institutions (11 additional sites)•Supervised Data and Coordinating Center staff while the consortium grew in both the number of collaborating sites (11) and clinical trials (7)•Supervised daily activities for 2 Research Study Assistants for each investigator-initiated, pharmaceutical, cooperative group, and multi-center trial•Worked with sponsoring pharmaceutical companies and their representatives•Facilitated the startup, on-study, and close-out activities of all multi-centered clinical trials•Managed and maintained patient and regulatory compliance for all participating sites•Created and maintained study protocols, Informed Consent Forms, Case Report Forms, study tools, and Standard Operating Procedures for each multi-center trial •Oversaw data collection, entry, and reporting for all trials•Performed quality assurance and compliance checks through real-time monitoring and query resolution

Department of Pediatrics, Clinical Trials OfficePediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC)

Conducted behavioral research on fear, stress and anxiety in rats• Specific research dealt with presenting laboratory rats with stimuli and studying, analyzing, and reporting on their behaviors

Bachelor Of Arts, Neuroscience, English

Activities and Societies: Sigma Kappa SororityMajor in Neuroscience, Minor in English

B.A, Neuroscience