Gwen K. Email and Phone Number

Function as a subject matter expert on all SSU-related activities in collaboration with other clinical research stakeholders and serves as a leader for local SSU process improvements.Including but not limited to:• Coordinate guide and assist with all start up activities prior to site activation• Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation.• Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams.• Track metrics and study start-up timelines to identify trends and opportunities for improvement.• Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met.

• Performs investigator recruitment activities utilizing phone scripts, questionnaires,study site materials and other tools for use in evaluating investigative sites.• Utilizes the Clinical Trial Management System (CTMS) of PRA to ensure investigatorrecruitment activities are accurately tracked.• Performs essential document collection, review, maintenance and close-out activities,ensuring that sponsor and investigator obligations are being met and are in compliancewith applicable local regulatory requirements and ICH/GCP guidelines.• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board(IRB)/Independent Ethics Committee (IEC) requirements.• Performs study tracking via CTMS or Sponsor designated system to ensure that thestudy files are current, accurate and complete.• Documents site and Sponsor contact and study interactions in a timely and professionalmanner.• Assists with resolution of investigational site/data queries.• Liaises with project team members regarding study site issues.• Provides quality review of the informed consent template.• Performs study duties in adherence to the protocol, Clinical Management Plan (CMP),study processes, ICH-GCP and any other requirements stipulated on the study.• Follows up with sites for trial invoices and ensures CTMS is accurately updated to allowthe timely processing of Investigator Payments.• Performs other duties as assigned.

• Maintains and distributes project documents including protocol/IDB, project plan,study timelines, Change in Scope Logas directed by Project Team.• Has oversight of purchase order process including raising and processing purchaseorders and processing study invoices.• System updates. Assembles and dispatches on-site investigator, pharmacy sites files (Master and Local).• Populates regulatory document templates.• Organizes and tracks translations following PRA systems/processes.• Routes study documents to Document Management.• Ensures documents within eTMF comply with filing/naming guidelines and have thecorrect status.• Tracks, dispatches and maintains study supplies following PRA process.• Creates and maintains essential documents packages including workflow processing.• Supports investigational sites.• Performs other duties as assigned.

Research and Development *Responsible for Stem cell cultured *Used Animal histological analysis to provide proof of product results for potential customers. *Responsible for biochemistry analysis to identify the cells or the tissues *Developed thorough research and development procedures, including experiments, proof of studies, and existing thesis, to satisfy objectives set by client *Formulated the standard protocols for HK headquarter *Responsible for purchasing required lab equipment and negotiate with providers for better pricings.Marketing: *Explore various marketing channels such as magazines, MRT, and evaluate each and every one of them base on target audience and product exposure to fully maximize the efficiency of our marketing budget. *Worked with Medical Associations to explore available exhibition best suitable for our products and update related issues of exhibitions. *Designed various product labels along with invitation and thank you cards for clients. *Product promotions through visiting numerous cosmetic and dental clinics to provide thorough presentation on product specifications. *Developed SOPs for clinics visiting, tissue collecting, and customers follow-up to ensure smooth future operation for fellow colleagues. *Developed appropriate Clinic Information Sheets and Customer Survey form to acquire critical information for customer evaluation.