Clinical Project Leader

• Jun 2018 - Present

-Support Clinical Project Leaders in the design, start up and management of multiple clinical projects within approved timelines/budget -Develops and maintains partnerships with CRO’s, clinical vendors and investigators -Liaise with CRO and clinical sites to monitor study progress -Acts as liaison with all internal and external partners regarding clinical projects -Provides supporting research for protocol designs and clinical FDA submission strategies; liaise with key opinion leaders, statisticians and consultants, as needed, to accomplish -Composes/ reviews study documents. (e.g. protocol, investigator’s brochure, source documentation, CRFs, informed consents, IRB submissions, project timelines, site selection questionnaire, Monitoring Plan, Communication Plan, Safety Management Plan, Statistical Analysis Plans, Data Management Plans, Edit Checks, and Clinical Study Report Shells) -Helps to coordinate investigator meetings and conduct presentations -Supervises the collection of regulatory documents and maintain project files -Supports the ordering, packaging, and shipping of clinical drug; maintain accountability logs -Maintains trial tracking spreadsheets, including enrollment, monitoring visit schedules, document tracking, tracking of drug and CRFs, etc; Track Key Performance Indicators -Ensures trials are properly monitored in accordance with GCP, FDA regulations and SOPs; Review CRO/auditor monitoring/audit reports and conduct co-monitoring or audits as needed -Develops systems to increase and assure study compliance Show less

Liaison to Clinical Trials Innovation

• Oct 2017 - Jun 2018

-Assist and support principle investigators and research staff to help streamline all aspects of clinical trials research -Act as liaison to Offices of Compliance, Sponsored Programs, Grants Management and Proposal Development -Train new staff on Good Clinical Practice and Stony Brook Medicine polices -Provide quarterly refreshment training to seasoned researchers -Mentor clinical research coordinators and research assistants -Obtain study metrics for Stony Brook Medicine NIH and industry clinical trials -Assist department leads in writing and preparing CTSA grant -Provide support to researchers with IRB submissions and approvals -Review study protocols and informed consents prior to IRB review -Provide researchers with patient recruitment strategies -Assist researchers with funding opportunities and start-up feasibility -Assist researchers with creating study budgets and budget justification -Preform quality assurance review of clinical trials, create corrective action plan as needed -Prepare researchers for IRB/Sponsor/FDA audits -Create tools and resources for research guidance -Assist with organizing events and meetings for CTS-C Show less

Senior Clinical Research Coordinator

• Dec 2014 - Oct 2017

Experience with Phase II-IV clinical trials in many different indications such as dermatology, gastrointestinal, urology, rheumatology and endocrinology -Responsibilities include: maintaining a thorough knowledge of a variety of medical conditions, and studies; recruiting, enrolling, consenting and counseling subjects; administering and accounting for all investigational products; performing all clinical assessments and procedures as indicated in the protocol (including, but not limited to, collecting blood samples, performing urine analysis, electrocardiograms, pulmonary function testing, etc); conducting maintenance visits throughout the length of each study; identifying and reporting adverse events and serious adverse events; creating source; mentoring other employees; participating in monitoring visits; internal monitoring; EDC data entry, study start up and close out; coordinating with sponsors and attending investigator meetings. Show less

Clinical Research Coordinator II

• May 2012 - Nov 2014

Experience with Phase II-IV clinical trials in many different indications such as dermatology, gastrointestinal, neurology, pulmonology and weight loss trials. -Responsibilities include: maintaining a thorough knowledge of a variety of medical conditions, and studies; recruiting, enrolling, consenting and counseling subjects; administering and accounting for all investigational products; performing all clinical assessments and procedures as indicated in the protocol (including, but not limited to, collecting blood samples, performing urine analysis, electrocardiograms, pulmonary function testing, etc); conducting maintenance visits throughout the length of each study; identifying and reporting adverse events and serious adverse events; creating source; mentoring other employees; participating in monitoring visits; internal monitoring; EDC data entry, study start up and close out; coordinating with sponsors and attending investigator meetings. Show less

Water Quality Intern

• Jun 2011 - Aug 2011