Responsibilities:• As APM (PM)to manage the study:• Take charge of the quality control & management of clinical study projects and the monitoring of major sites, if necessary; ensure the study process in strict accordance with the protocol, related SOP and laws & regulations;• Develop the master schedule for study projects, assist CRA in the developing detailed schedules for participating sites, and ensure the initiation, performance and closing of study projects on schedule, communicate with other personnel such as medical writers and data management & statistical analysis staff, if necessary;• Collect materials as CRF, original medical records, project management form in compliance with the protocol for the superior’s necessary review, and submit the ethic materials of the head site for the approval letter of Ethics Committee;• Review the clinical study contracts of each site and instruct CRA with negotiating & contracting;• Train the project team members prior to project initiation, ensure the initiation of each site on schedule, and review all reports from the team members, keep the efficient communication channel with all involved personnel, and take charge of the routine quality control and progress reports during study projects;• See to the teaching & training and routine management of team members(CRA), assist CRA with the monitoring plan, and come up with a viable plan by which to perform selective collaborative monitoring of study sites to ensure the trial schedule and trial quality;• Set up and cultivate a good cooperation relationship with investigators(study sites);• Take charge of the communication of data management dept., statistical analysis dept. and medical affairs dept.; ensure the data management plan/report, statistical analysis plan/report, and Q&A, data review meeting, closing meeting and final report done as planned;• Assist in other work required by the superior.

• Make the training plan of 2017 Year; Conduct the training plan of 2016 Year, complete all training plan ;• Train the new employees about the SOPs and GCP;• According to the training plan, design topic, collecting materials, making PPT of the speech;• Organize and attend CO training routine training, mainly explained the involving of biomedical research ethics review method, pediatric population drug clinical trial;• Organize and attend English training;

• Monitor (pre-study, IMV, MIV, and COV) at investigator sites. Conduct on-site monitoring: review overall site performance; ensure investigator’s adherence to protocol and GCP; review Informed Consent Forms, perform source data verification; review SAE reports and make sure reporting procedures following to SOPs and ICH-GCP; collect CRFs and review queries resolution; review investigational products accountability and review storage condition;• Perform all duties of a CRA, serving as the primary contact with individual investigative sites that conduct clinical research.• Track enrollment status reports to ensure study stays on track to meet enrollment goals.• Responsible for clinical drug safety information collecting, timely and accurate reporting occurred during clinical trials, adverse events or serious adverse events on demand.• Manage investigational products and Study documents management;• To conduct the exhaustive quality control and management of the responsible clinical trials;• To transfer information in time and to keep good relationship with sponsors and investigators;• Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues.• Review outstanding data reports and work with CRAs to ensure data collection is met per contractual guidelines.• Develop study-specific monitoring tools and forms for use by monitoring team to assist in efficient review of study data.

Responsibilities: • Supporting sponsors for screening the potential investigators / study site identification, and collect Feasibility Questionnaire and CDA;• Organize and attend study related meetings, e.g. investigator meeting, project team meeting as required;• Communicate with IEC as required;• Review the submission documents;• Prepare the submission documents;• To communicate with the regulatory authority;• Negotiate study finance agreement with investigators and investigator payment management;• Monitor (pre-study, IMV, MIV, and COV) at investigator sites (50-70% travel). Conduct clinical trials according to ICH-GCP, company SOPs, regulatory requirements and sponsor’s requirements;• Conduct on-site monitoring: review overall site performance; ensure investigator’s adherence to protocol and GCP; review Informed Consent Forms, perform source data verification; review SAE reports and make sure reporting procedures following to SOPs and ICH-GCP; collect CRFs and review queries resolution; review investigational products accountability and review storage condition;• Manage investigational products and Study documents management;• To conduct the exhaustive quality control and management of the responsible clinical trials;• To transfer information in time and to keep good relationship with sponsors and investigators;

Responsibilities: • Responsible for marketing development, and customer communication work;• Medical device registration and application reporting;• Medical device clinical trials;• Development and registration of health food research;Achievements:• Monitor 2 sites for Phase III study, orthopedics department - 2 sites, 60 subjects.