Sr. Clinical Project Manager

• Mar 2021 - Present

Clinical Project Manager

• Feb 2019 - Mar 2021

• Manages the conduct of clinical research trials. Facilitates collaborative efforts among the clinical study team, principal investigators and data management on preparation of study protocols and related documents for sponsor-initiated clinical trials, and the execution and completion of such trials. • Directs the selection of investigational sites and selection of vendors. Manages supplier relationships and supplier activities (e.g., CROs, data management services). Oversees management of GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines. • Develops and oversees Clinical Trial Master Files according to applicable domestic and/or international regulations and internal SOPs. Oversees the process of filing, maintenance and archiving of study documentation. • Leads and conducts training and initiation of clinical sites participating in CapsoVision clinical trials. • Manages study data collection (monitoring), data entry, and timely data reporting. • Tracks and assures clinical milestones (i.e., enrollment, site start-ups, completion of studies) are met; oversees collection, synthesis and reporting of trial progress information. • Mentors/trains in-house or contract CRAs. • Drives relationships with clinical sites and key vendors to successfully complete projects with requisite quality, expected timelines and within budget. • Supervises conduct of routine quality audits to ensure that clinical sites and outsourced suppliers maintain necessary study documentation and adhere to protocol requirements. • Prepare clinical study reports and collaborates with Regulatory Affairs in preparing regulatory filings and reporting study data to FDA or foreign Competent Authorities as necessary. • Coach and support project team members with tasks that was assigned Show less

Clinical Research Coordinator

• May 2018 - Feb 2019

• Managed in recruiting, screening, instructing, and coordinating with research subject via phone and in-person. • Managed in reviewing inclusive/exclusive criterias with research subjects. • Managed in planning and coordinating the initiation of research study protocols and establishing operating policies and procedures. • Managed in planning, implementing, and maintaining data collection and analysis systems in support of research protocols; and in coordinating the collection and analysis of research data. • Prepared and reviewed IRB documents. • Ensuring the smooth and efficient day-to-day operation of research and data collection activities. • Acting as the primary administrative point of contact for internal research staff and as the principal operational liaison for other research organizations, funding agencies and regulating bodies. • Performs biospecimen/EKG/vitals and prepare for distribution. • Monitor the progress of research studies; developed and maintained records of research activities as required by investigators, administrators, funding agencies, and regulatory bodies. Show less

Clinical Research Associate Consultant (Medical Device/Interventional Drug)

• Feb 2017 - May 2018

• Work closely with lead Admin and PI to prepare for Monitor Site Qualifying screening. • Work with non-traditional site to develop and design all SOP, such as Inform Consent, Recruiment process, study medication administration, caregiver procecure, rater’s procedure, chart and tracking procedure..etc. • Design and create clilnicial study department by identifying roles per protocol requirement. • Lead and managed creating tasks for the Clinical Trials • Work with PI and to Identify recruitment strategies. • Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections. • Identified, screened, and recruit study sites of more than 360 patients for a start-up A1C Care clinical evaluation trial. • Conducts Site Qualification, initiation visits, on-site monitoring visits, on-site monitoring visitions, and site closure visits. • Lead and managed all tasks for the Clinical evaluation trial from start to close-out. • Monitor the progress of the clinical evaluation study at investigative sites and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOP, and all applicable regulatory requirements. • Identified and worked closely with IRB for protocol submission. • Coordinates with PIs and study staff to help ensure that clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures. • Managed work activities in a time and cost effective manner to ensure budgetary guidelines and project timelines are met. • Performs specimen processing, shipment of biological specimen, and phlebotomy duties, as needed. Show less

Clinical Research Coordinator

• Mar 2016 - May 2017

• Responsible for managing day-to-day operations of a grant-funded survey research project involving more than 800 participants at 9 medical centers. • Recruit focus group participants, convene focus groups, and assist in interpretation of findings. • Identify clinical trial principal investigators (PIs) to approach for potential study participation; “pitch” the study to PIs, address their concerns, and negotiate agreements to include their research participants in the survey. • Work with staff of participating clinical trials to develop appropriate methods for survey recruitment and administration and satisfy multiple sites’ IRB requirements. • Implement participant recruitment and informed consent materials, focus group guides, and survey questionnaires in collaboration with faculty members. • Lead all aspects of survey administration, including mailings, data entry, follow-up contacts, tracking of responses, payment of incentives, and supervision of a Research Assistant. • Assist in programming survey questionnaires in REDCap. • Develop systems for tracking study progress. • Prepare agendas for study team meetings and interact with the PI regularly, ensuring timely study progress and strict adherence to study protocol. • Respond to survey participants’ questions. • Participate in drafting project presentations, progress reports, and manuscripts. • Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. Show less

Clinical Research Coordinator (Medical Device/Interventional Drug)

• Jan 2013 - Mar 2016

• Assisted in planning and coordinating the initiation of research study protocols and establishing operating policies and procedures. • Assisted in planning, implementing, and maintaining data collection and analysis systems in support of research protocols; and in coordinating the collection and analysis of research data. • Prepared and reviewed IRB documents. • Recruited, instructed, and coordinated research participants. • Ensured the smooth and efficient day-to-day operation of research and data collection activities. • Acted as the primary administrative point of contact for internal research staff and as the principal operational liaison for other research organizations, funding agencies and regulating bodies. • Planned and coordinated the staffing of research studies, including recruitment and administration of research support staff. • Monitored the progress of research studies; developed and maintained records of research activities; and prepared periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and regulatory bodies. Show less

HR Manager

• Sep 2007 - May 2014

• Managed and handled day-to-day Human Resources activities for a growing firm of 45 employees. • Assisted in implementing HR programs and policies. • Responsible for New hire orientations, terminations, Benefits Insurance activities, offer letters for new hires, and contractors agreement • Support in Employee relations issues and all immigration visas • Managed and handled day-to-day Human Resources activities for a growing firm of 45 employees. • Assisted in implementing HR programs and policies. • Responsible for New hire orientations, terminations, Benefits Insurance activities, offer letters for new hires, and contractors agreement • Support in Employee relations issues and all immigration visas

HR Manager

• Sep 2001 - Aug 2007

• Handled all HR related issues, employee trainings, immigration, Benefits, and contractor screening. • Partner in reviewing and implemented a new HRIS system, facilitated all compliance requirements, and developed the policies in the company Handbook. . • Managed and handles all annual audits (401k, stock, salary, and worker’s comp plan). • Handled all HR related issues, employee trainings, immigration, Benefits, and contractor screening. • Partner in reviewing and implemented a new HRIS system, facilitated all compliance requirements, and developed the policies in the company Handbook. . • Managed and handles all annual audits (401k, stock, salary, and worker’s comp plan).

HR Representative III

• 2000 - 2001

• Responsible and support all HR related matters for three divisions at PRI West: OEM Systems Division, Tools Connectivity Division (TCD), & Application, Planning, & Scheduling (APS). • Responsible and support all HR related matters for three divisions at PRI West: OEM Systems Division, Tools Connectivity Division (TCD), & Application, Planning, & Scheduling (APS).

HR Representative I

• 1999 - 2000

• Partner with hiring managers to recruits all levels of Software, Hardware, systems, Application, and Unix Admin positions • Partner with hiring managers to recruits all levels of Software, Hardware, systems, Application, and Unix Admin positions