Member Board of Directors

• Feb 2023 - Present

Clinical Operations Project Manager

• Jan 2023 - Present

Currently working as a contractor at the Yale center for Clinical Investigation on decentralized Long COVID research. Currently working as a contractor at the Yale center for Clinical Investigation on decentralized Long COVID research.

Clinical Study Specialist

• May 2021 - Jan 2023

Program Manager

• Jun 2018 - Apr 2021

•Manage the regulatory, administrative and financial responsibilities of the division. •Supervised 8 Research assistants •Create job posting for Columbia University (CU), and RFMH, interview applicants, review and approve timesheets, as the liaison for the Principal Investigators (PI) and the Human Resources department. •Develop and implement standard operating procedures in collaboration with the PIs and research team. •Submit initial applications to the IRB and oversee subsequent submissions, such as, amendments/modifications, SAE, continuations, and closeout reports. •Oversee the development of source document templates, case report forms, study binders, and regulatory binders for all active study protocols. Ensure that study binders and databases are kept up to date. •Prepare and submit Investigational New Drug Applications, protocol amendments, and annual progress reports to the FDA. •Create and maintain Clinicaltrials.gov records for all active clinical trials. •Prepare and manage grant application submissions by preparing budgets and budget justifications, and by ensuring application deliverables are submitted in accordance with deadlines set by the sponsor, prime and subcontract institutions. •Provide ongoing grant management, including submissions of Just in Time pre-award materials, post-award Progress Reports, and budget management. •Maintain up-to-date biosketches, other support, Citi training, and all study/grant-related documents. •Prepare and submit all post-award financial transactions for the division, including the preparation of all purchase orders, invoices, travel reimbursements, subject payments, consultant payments, petty cash, etc., for RFMH and Columbia University grants. •Assist in the execution of Contract agreements (Material Transfer Agreements, Business Associate Agreements, Data Use Agreements, etc.) •Coordinate the PGY-1 Geriatric rotation with residents through the Clinic on Aging, Anxiety, and Mood Disorders. Show less

Clinical Research Management System Specialist

• May 2017 - Feb 2018

•Successfully supported the implementation of the Clinical Trial Management System (CRMS), a system for clinical trials, which is used for billing, building protocol schemas, calendars, budgets, and capturing participant visit data. •Actively engaged with study team and central office team members to gather, analyze, and assimilate documents required to build calendars in CRMS (i.e., research protocol, IRB application, consent form, etc.). •Collaborate with team members to represent the study calendar and budget data in the system. •Identify obstacles encountered during the calendar build process; communicate and develop acceptable resolutions to such obstacles. •Ensure subject visits and procedure details are consistent with legacy system documentation. •Review contracts and fixed costs and create Excel files to determine invoicable items and enter into the new system by having an understanding of clinical trials and/or grant contracts. •Collaborate with post award staff to represent legacy invoicing and payment data. •Cash applications and reconcile payments of invoiced items •Understand various software systems and the interdependencies between systems. •Supported special projects requiring QA input by leading quality auditing activities to ensure that studies are built in the CRMS system in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations. •Confirm clinical trial study reports against source data for accuracy, integrity and consistency. •Provided training to colleagues needing assistance in understanding study protocols, billing procedures, GCP guidelines, etc. •Experience with the following therapeutic areas: Cardiology, Otolaryngology, Gastroenterology, Cardiothoracic Surgery, Pulmonary, Rheumatology, Neurosurgery, Orthopedics Surgery, Oncology, Pediatrics, Neurology, Plastic Surgery, and Transplant Show less

Regulatory Compliance Coordinator

• Jun 2016 - May 2017

• Responsible for domestic and international regulatory activities associated with FDA, ISO and international regulations for the cardiovascular research department. •Ensures timely submissions of all regulatory aspects of over 70 clinical trials •Provide regulatory support to clinical trial project teams •Ensures necessary required regulatory documents are on file for proper study start-up and initiation. •Ensure QA of submissions by working directly with in-house IRB as well as other central IRB •Acts as a liaison for investigators, research coordinators and other study staff with sponsor organization, pharmaceutical companies and medical device companies in coordinating regulatory aspects of study. •Ensures proper training and documentation of training for all staff. •Develop and/or revise regulatory policies and procedures. •Prepares the department, investigator and clinical staff for audits, both internal and by the Food and Drug Administration Show less

Clinical Research Coordinator

• Jul 2015 - Jun 2016

• As a Cardiometabolic Clinical Research Coordinator, I ensured that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures. • Review and develop a familiarity with study protocols, which include, but are not limited to, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections. • Facilitate and coordinate daily clinical trial activities and play a critical role in the conduct of the study • Successful in recruiting a large number of subjects for cholesterol lowering therapy trials, in a short period of time. • Educate patients on study expectancies and investigational drug compliance, review of adverse events and patient follow-up • Conduct tests and procedures on study participants, such as electrocardiograms, blood draws, vital signs and other test indicated in study protocol • Develop and implement recruitment strategies, complete IRB correspondence with experience in InfoED, Mount Sinai IRB, Schulman IRB, Western IRB and BRANY. • Successful collaboration with sponsors such as, Amgen Pharmaceutical, Sanofi/Regeneron, The Medicines Company, AstraZeneca and Catabasis Show less

Store Manager

• Oct 2014 - Jan 2015

Sports Medicine Intern

• Aug 2014 - Jan 2015

•Assist the Doctor in obtaining patient history. •Take vital signs as needed, as well as, perform physical assessments on patients. •Assist the Doctor in the application of certain medical devices, such as electrical stimulation therapy. •Billing of insurance and updated patient history in the electronic medical record. •Ensured the patients felt at ease and also maintained HIPPA compliance as designated by the state of California. •Assist the Doctor in obtaining patient history. •Take vital signs as needed, as well as, perform physical assessments on patients. •Assist the Doctor in the application of certain medical devices, such as electrical stimulation therapy. •Billing of insurance and updated patient history in the electronic medical record. •Ensured the patients felt at ease and also maintained HIPPA compliance as designated by the state of California.

Dental Assistant

• May 2014 - Aug 2014

Field Interviewer

• Mar 2014 - Aug 2014

Patient Care Associate

• Oct 2010 - Aug 2013

•At the Recanati/Miller Transplant Institute, I assisted patients with their activities of daily living, which include but are not limited to helping patients bathe, walk, empty their drains, while documenting necessary information in their electronic medical record. • Checked patients vital signs, perform electrocardiograms and phlebotomy. •Ensure patients receive the best care possible by following essential guidelines and precautions established by the transplant team. •At the Recanati/Miller Transplant Institute, I assisted patients with their activities of daily living, which include but are not limited to helping patients bathe, walk, empty their drains, while documenting necessary information in their electronic medical record. • Checked patients vital signs, perform electrocardiograms and phlebotomy. •Ensure patients receive the best care possible by following essential guidelines and precautions established by the transplant team.

Research Assistant

• Jan 2012 - May 2012

•As part of the Emerging Scholars program, I worked collaboratively with a professor and a fellow assistant researcher in the development and organization of a scientific poster on Endocrine disrupting chemicals and their effect on maturing children •I participated in various workshops; which provided information on the production of an effective scientific project. •Research team would meet weekly and discuss any additional information allocated. •The poster was then presented at the Emerging Scholars Symposium. Show less

Patient Care Associate

• Jan 2010 - Aug 2010

•As part of the nursing staff in the post –cardio thoracic unit, I assisted patients in their activities of daily living. •Obtained vital signs, weighed patients, and checked their glucose levels while ensuring to document direct patient care as needed. •I acted as an advocate for patients who had any problems with their care and relayed the information to the appropriate party. •As part of the nursing staff in the post –cardio thoracic unit, I assisted patients in their activities of daily living. •Obtained vital signs, weighed patients, and checked their glucose levels while ensuring to document direct patient care as needed. •I acted as an advocate for patients who had any problems with their care and relayed the information to the appropriate party.