- Act as a primary point of contact for new trials, perform feasibility assessment and budget/contract negotiation, and act as a signatory for all research agreements.- Plan and supervise recruitment plans for enrolling clinical trials.- Ensure regulatory compliance with guidelines, rules, and laws that govern clinical research.- Manage clinical studies and ensure all study deliverables are met on schedule.- Coordinate efforts between study investigators and the clinical research team.- Develop operating procedures and quality assurance plans.

- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead and/or line manager.- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.- Prepare sites FDA inspection and sponsor audit-ready.

- Developed and wrote investigator-initiated trial protocols and informed consent forms.- Worked on IRB submissions (Initial Application, Continuing Review, Modification, Protocol Deviation/Violation, Safety Reporting).- Worked with sponsors to set up and initiate trials at the trial sites.- Developed study tools (e.g., tracking forms, questionnaires, chart review forms, etc.).- Coordinated and monitored study activities of projects throughout duration of the studies.- Verified and ensured quality of study data, source documents, and case report forms.- Drafted project progress reports collaboratively.- Trained new team members and clinical staff.- Adhered to compliance and privacy/confidentiality requirements and standards. Adhered to GCP and compliance regulations for clinical trials.- Identified, recommended and implemented solutions to study issues.- Contributed to portions of study presentations.- Reviewed scientific literature, synthesized and summarized information.- Ensured Investigational Product/Device and study materials.

- Developed recruitment strategies for assigned projects and/or populations of interest.- Performed as a psychometrician for CNS studies.- Assessed feasibility and risks during new study start-up processes.- Coordinated study activities according to study protocols and CFR/ ICH-GCP guidelines and ensured study participant eligibility. Obtained informed consents from study participants.- Trained department staff on new protocols.- Updated and maintained contents of the Clinical Study File.

- Conducted protocol study visits and protocol-specific procedures.- Assisted study investigators in assessments on concomitant medications, adverse events, lab results and other test results.- Completed case report forms (CRF) and assured quality and accuracy of source and CRF documentations.- Recruited study participants and hosted company-sponsored community events.

- Involved in Adaptive and Perceptual Learning in Chemistry Education Project led by Dr. Kojima and Dr. Kellman at Human Perception Laboratory.- Instructed and administered computer-based assessments to study participants.- Assisted IT team in design and development of assessment programs.- Participated in analysis and synthesis of outcomes.

- Performed standardized laboratory tests to verify chemical characteristics of solutions.- Prepared chemical solutions for undergraduate general and organic chemistry laboratories. - Assisted undergraduate students in performing experiments.

- Researched scientific journals and articles upon researchers’ requests.- Filed and organized Material Safety Data Sheets (MSDS).- Prepared chemical samples and basic solutions.