7+ years diverse background in Academic and Clinical Research Organization (CRO) encompassing administration and clinical study management for large multi-site studies (domestic and international). Experience with pre-award, post-award and closeout procedures. Strong hands-on experience with federal agency (NIMH, PCORI, NINDS, NCBI) grant submissions and processes. Applies business, financial, project and trial management acumen to manage and deliver successful multi-million dollar research projects. Strong organizational and management skills: meets and sets deadlines; able to successfully manage workflow for several projects simultaneously; work under pressure; staff management and able to complete projects independently with minimal supervision. Expertise in coordinating and providing guidance for day-to-day operational activities of study-related contractors. Knowledge across multiples clinical trial phases and therapeutic areas such as: Cardiovascular Diseases, Neurology, Hematology, Psychiatric and Oncology. Strong proficiency in monitoring and study management of: FDA clinical trials; federal sponsored projects; and Cooperative Groups. Direct knowledge and participation in regulatory, FDA, financial audits. Expertise in coordinating between sponsor, sub-contractors, and the research centers participating in the studies. Expertise in directing complex research studies Work with various Electronic Data Capture (EDC) systems to ensure data completeness and query resolution. Knowledge of Good Clinical Practice, Code of Federal Regulations, clinical trial design, regulatory processes, and global study management. Experience in developing effective relationships with key investigators and site personnel. Expertise Institution Review Board (IRB) processes and regulations. Strong understanding of clinical trial documents (protocols, source documents, case report forms, Standard Operating Procedures (SOP), study reports and processes).
The ARUBA Trial: Current Status, Future Hopes.
Association of the T300A non-synonymous variant of the ATG16L1 gene with susceptibility to pediatric Crohn's disease.
Association of Variants of the Interleukin-23 Receptor Gene with Susceptibility to Pediatric Crohn's Disease.
High-resolution mapping and analysis of copy number variations in the human genome: A data resource for clinical and research applications.
Program Administrative Director, 11/2010 － CurrentColumbia University － New York, NY
Division of Mental Health Services and Policy Research Work individually and collaboratively with the Principal Investigator of the Schizophrenia Trials Network in the overall coordination and management of NIMH-sponsored multi-site clinical trials.
Work closely with Sponsor Projects Administration (SPA) and Clinical Trial Office (CTO) in the pre- and post-award, and in the closeout of grant/contract activities.
Work closely with Sponsor Projects Financial (SPF) and department business office in the post-award financial administration of sponsored programs activities such as financial reporting, financial status, billing, and collection of payment from sponsors, research site payments and closing projects.
Responsible for the financial operations of the program; coordinate and process the daily financial transactions to ensure compliance with the University guidelines and funding agency regulations; oversee accounts payable transactions on the University electronic accounting systems.
Manage grant submiss.
Program Leader, 04/2009 － 11/2010Mount Sinai School of Medicine International Cen － New York, NY
Work individually and collaboratively with the Principal investigator (s) for the overall coordination and management of two multi-site clinical trials sponsored by the NIH.
Assisted with grant applications and budget development.
Oversaw and coordinated the activities of professional staff, monitors and coordinators which included assignment of work and special projects, and monitoring workload.
Communicated up-to-date information regarding trial progress to all relevant interested parties.
Management of patient recruitment strategies to increase patient randomization into the trial (e.g.- investigator and research nurse meetings, update newsletters, advertising and marketing).
Developed site initiation training and investigator meeting materials.
Assisted with the collection of required regulatory documentation for site activation.
Oversaw the compilation of Adverse Event information.
Performed site initiation and protocol training to ensure proper site adherence to clinical research regulati.
Sr.Clinical Research Coordinator, 04/2007 － 04/2009Mount Sinai School of Medicine The Tisch Cancer － New York, NY
Work individually and collaboratively with the Principal investigator (s) for the overall coordination and management of 20 FDA clinical trials.
Responsible for monitoring the Cooperative Group trials in New York City (review source documentation, case report forms, electronic data entered and data reports for accuracy and ensure the timely submission of such documentation) to ensure compliance with the protocols, investigational plans, monitoring plans, applicable regulatory, IRB standards, guidelines and policies.
Work closely with the Office Administrator Director in financial administration activities, such as billing, and collection of payment from sponsors.
Assisted the clinical medical director in hiring; training and supervision coordinators.
Prepared and participated in audits including those with pharmaceutical sponsors, Cooperative Groups and the FDA.
Coordinated research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
Research Assistant, 01/2006 － 01/2007The Childrens Hospital of Philadelphia － Philadelphia, PA
Collected and maintained study data as required for specific clinical research protocol.
Assisted with budget development, billing and quarterly financial reporting.
Assisted with quality improvement activities as related to research protocol.
Helped in Designing questionnaires and other methods to collect quantitative data.
Collected and inputted qualitative data from interviews, non-participant observations or focus groups.
Monitored daily recruitment, synchronized data collection with the database server, and maintained data queries.
Subject recruitment, screening, consenting and pre-registration.
Assisted project manager in the preparation of IRB submissions and grant proposals.
Senior Medical Assistant, 01/2003 － 01/2006The Mount Sinai Hospital Internal Medicine Assoc － New York, NY
Performed varied administrative tasks needed to run an efficient office such as scheduling hospital admissions and surgery, laboratory tests, and coordinated patient care with other departments involved during patient hospitalization.
Acted as research assistant as needed.
Assisted research team with survey, budget, consent and study procedure Assisted physicians, residents in examination and surgical procedures of patients Established vital patient data according to specified patient treatment, which included: performing electrocardiograms, recording patient height, weight and vital signs, draws blood, test urine dip stick.
Trained new Medical Assistants.
Nurse's Technician, 01/1999 － 01/2003The Mount Sinai Hospital － Queens, NY
Monitored and reported changes in the patient's mental and physical condition.
Provided direct care to patients undergoing diagnostic and therapeutic congenital cardiovascular and electrophysiology procedures.
Administered the use of medical equipment and supplies.
Provider of translation services for large cohort of Hispanic patients and their families.
Assisted physicians and nurses in examination and surgical procedures of patients by preparation of patient, assisting with instruments, bandages, instructing patients in post-operative care, and correct handling of specimens, cultures and the like.
Education and Training
09-2001Empire Career － New York, NYCertified Nurse Technician
06-2006The Children Hospital of Philadelphia － Philadelphia, PACertified Clinical Research Coordinator
05-2009New York Institute of Technology － New York, NYMBAHealth Care Administration
04-2007New York Institute of Technology － New York, NYBachelor of Science
Member of Association of Clinical Research Professional Golden Key International Honor society Delta Mu Delta Member of Project Manager Institute 4