Responsible for evaluation, initiation, routine monitoring and close out visits at each assigned study.Conduct monitoring visits to assess protocol adherence; assess qualification of study personnel; conduct source verification; verify drug accountability and storage requirements; and ensure compliance with regulatory requirements and AE reporting requirements. Ensure subject safety and adverse event reporting to sponsor and IRB/IECPerform investigative site file reconciliation; request any new and updated site-related essential and non-essential documents and review them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, and project Standard Operating Procedures (SOPs), and sponsor requirements.

Supported the project team with the document management and other related tasks to meet timelines and milestones for Phase II clinical trials.Assisted with the coordination and tracking of documents, materials and supplies for assigned projects.Support the updating and maintenance of tracking tools, timelines and project plans with project specific information.Collected and reviewed completed study documents and track status of study documents.Ensured that study documents are correctly filed electronically and assist with review of files for accuracy and completeness.Interacted with sites and clinical team to resolve issues with Study Documents and Clinical Data.Participated in internal and sponsor study team meetings.

Reviewed Study Protocols, ICFs, Regulatory documents and monitoring reports for accuracy in accordance with GCP and ICH guidelinesCompiled Investigational Product (IP) release packets for clients with essential regulatory documents Communicated with investigator sites on various matters in regards to study start-up Assisted in conducting an interim monitoring visit, completed monitoring report and wrote follow up letterParticipated in internal and study team meetingsAssisted in business development activities

Responsible for interfacing between investigators and CROs in experimental design, writing and editing protocolsConducted in-depth data analysis and communication of study results Involved in exchange of drug and study samples and preparation of dosing solutions Updated and maintained database Assisted in the start-up, scheduling, maintenance, tracking and close-out of various projects

Developed autoradiography and IV infusion methods for drug targets. Responsibilities included: ligand preparation, dosing, brain and blood collection, cryo-sectioning tissues, image quantification and analysis. Data from these experiments were used to drive lead optimization program.

Characterized the effects of investigational drugs in rodent models relevant to psychiatric disease (e.g. forced swim test, olfactory bulbectomy, LH, Novelty induced drinking); experimental design; drug preparation; dosing (p.o., i.p., i.m., s.c. & i.c.v.); blood, CSF collection & brain harvest; data collection, analysis, and presentation.

Performed jugular vein cannulations for intravenous delivery of drugs and tracheotomies in rats for a MI rat model; Implanted mini-pumps intraperitoneally & subcutaneously for chronic studies

Performed transient and permanent left anterior descending coronary artery Occlusion (LADCAO) in the myocardial ischemia/infarction rat model to determine novel compounds’ ability to reverse/prevent myocardial infarction. Recorded ECG readings during surgical procedures for evaluation of cardiac arrhythmias; Analyzed raw data & presented data to project team and research department.Performed CK, Troponin, and Myoglobin analysis using the Stratus CS analyzer for rapid measure of cardiac markers.