o Participate in the development of the protocol, protocol revisions and amendments, monitoring plan and operational processes.o Provide input into the development of the CRF (data capture forms)o Collaborate with the TA(s) management staff & cross-functional management teams, in development of budgets and timelines for new studies. o Insure SAE reporting compliance requirements o Facilitate and assist with SAE medical review. o Assist medical and project leaders with… Show more o Participate in the development of the protocol, protocol revisions and amendments, monitoring plan and operational processes.o Provide input into the development of the CRF (data capture forms)o Collaborate with the TA(s) management staff & cross-functional management teams, in development of budgets and timelines for new studies. o Insure SAE reporting compliance requirements o Facilitate and assist with SAE medical review. o Assist medical and project leaders with safety reporting compliance. o Calculate clinical and non-clinical IMP requirements. o Oversee site clinical supply inventory Monitoring Activities o Provide guidance to study monitors for assessment, resolution, and documentation of both routine and complex site and study issues. o Provide coaching and mentoring to monitoring staff as needed to team members for GCP compliance.o Review visit reports and escalate issues to medical and operational leaders. o Perform activities of Lead CRAs on a temporary basis as needed to insure on time quality driven deliverables. o Conduct co monitoring visits to assess site and monitor performanceo Review query aging reports against timeline and work with functional team members or CRO to resolve queries according to plan.o Perform ongoing vendor management performance management and issue resolution.o May assist with development of scope of work and budgets, o Ensures accuracy and timeliness of vendor and site paymentsRegulatory o Have an understanding of IND/NDA and other HA submission requirements. o Assist with the review and revision of new and revised IND documents. o Conduct quality control (QC) audits on annual and ad hoc IND updates. o Functional Group/ Therapeutic Area(s) Support and Strategic Planning Ensure trial adherence to ICH/GCP/local regulations business-partner communication for proactive study-wide problem solving regarding study progress. Show less

•Build relationships with investigators and site staff•Perform on-site visits in accordance with the monitoring plan; apply judgment and knowledge to independently resolve site issues, questions and concerns •Monitor patient safety onsite and address protocol violations and immediately provide report and recommendations to Functional Lead(s) •Monitor and maintain completeness and quality of the on-site files •Organize translations per country/regulatory/client… Show more •Build relationships with investigators and site staff•Perform on-site visits in accordance with the monitoring plan; apply judgment and knowledge to independently resolve site issues, questions and concerns •Monitor patient safety onsite and address protocol violations and immediately provide report and recommendations to Functional Lead(s) •Monitor and maintain completeness and quality of the on-site files •Organize translations per country/regulatory/client requirements•Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments•Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)•Prepare and negotiate as required initial and/or amended CSA at a site level•Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required Show less

•Providing training to Clinical Research Nurse •Management Clinical Research Nurse resource•Reviewing Clinical Trials Contract and negotiation study budget•Interact with direct report and external customers to archive study milestone•Assisting to large multinational clinical trial submission to RA and IRB•Set-up new clinical study team for each divisions in hospital.

•Implementation Phase I clinical trials for 2、Phase III for 1 in Oncology scope •Implementation Phase I clinical trials for 3、Phase II for 2 in Hepatic scope•Implementation Phase II clinical trial for 1 in Neurology scope •Implementation Phase IV clinical trials for 3 in Gastroenterology scope•Implementation Phase I clinical trial for 1、Phase II for 1 in Cardiovascular scope•Implementation Phase I clinical trial for 1、Phase II for 1 in Medical Device