Kitty Chen Email & Phone Number

Taipei City, Taiwan

Taipei City, Taiwan

Project Manager (Aug 2017-Aug2018), Functional Project Manager (Mar 2016- Jul 2017)Professional Achievements1. Accounted for 7 clinical trials( indication: HIV, NSCLC, Brain cancer, MRI contrast, GHD Adult and child) as project manager role, including 4 clinical trials are global studies.2. Completed 2 clinical trials and transferred all TMF and relative document to sponsor.3. Assist 2 TFDA on-site GCP inspections as Project manager role, all of which agreed to be available for reference.Job Description1. Manage interdisciplinary clinical research projects and lead clinical team to ensure on-time, on-budget performance of project.2. Review, develop and approve Case Report Forms (CRFs).3. Review and approve investigator budgets and contracts.4. Review and approve regulatory and administrative documents from investigators sites.5. Plan, coordinate and present at investigator meetings.6. Review and approve monitoring reports.7. Participate in periodic in-house project status review, including project financial review, with senior management.8. Manage third party vendors on project basis, as needed.9. Review and approve invoices to clients.10. Review proposal costing for relevant clinical activities.11. Review and provide input to proposal documents.

Taipei City, Taiwan

Professional Achievements1. Accounted for 7 clinical trials (indication: HIV, Solid tumor, HCV, NSCLC, MDS).2. Accounted for 16 sites' activities, including contract negotiation, SIV, interim MV, SCOV, assist site interim report, protocol deviation report, site audit preparation and relative site issue resolution.3. Assist 2 TFDA on-site GCP inspections as CRA role, all of which agreed to be available for reference.Job ObjectiveResponsible for monitoring and managing the conduct of clinical projects according to ICH-GCP, Standard Operating Procedures (SOP) and applicable Study Specific Procedures (SSP) and local regulatory requirements. In addition to the responsibilities as a CRA, the SCRA provides mentoring and coaching for junior personnel, and supports department training programs as a trainer and/or a topic expert.

New Taipei City, Taiwan

Professional Achievements1. žAccounted for 2 clinical trials (indication: angina, Echo contrast).2. Accounted for 10 sites' activities, including contract negotiation, SIV, interim MV, SCOV, assist site interim report, protocol deviation report, site audit preparation and relative site issue resolution.3. Achieved subject recruitment target on time.Job Objective1. As Home-Based CRA responsible for all the processes from startup to close out and all the submission/ administration affairs.2. Accomplished the IRB/IEC and TFDA submission packages.3. Account for all site activities and site management.4. Account for site issues and site communicate.

Taipei City, Taiwan

Professional Achievements1. Accounted for 4 post-marketing studies (indication: Hypertension, PAD, DM, Af).2. Accounted for 58 sites' activities, including contract negotiation, SIV, interim MV, SCOV, assist site interim report and relative site issue resolution.3. Achieved subject recruitment target on time.Job Objective1. Outsourcing at sanofi-aventis Taiwan.2. Accounted for post-marketing studies.3. Accomplished the IRB/IEC and TFDA submission packages.4. Account for all site activities and site management and mostly in-house monitoring for paper CRF.5. Account for site issues and site communicate.

Taipei City, Taiwan

Professional Achievements1. Accounted for 7 clinical trials(indication: Acute Coronary Syndrome, Insomnia, infertility).2. Accounted for 11 sites' activities, including contract negotiation, SIV, interim MV, SCOV, assist site interim report, protocol deviation report, site audit preparation and relative site issue resolution.3. Achieved subject recruitment target on time.Job Objective1. Accomplished the IRB/IEC and TFDA submission packages.2. Account for all site activities and site management.3. Account for site issues and site communicate.

Taipei City, Taiwan

Taipei City, Taiwan

Master'S Degree, Nursing

Bachelor'S Degree, Registered Nursing/Registered Nurse

Activities and Societies: Chinese Music Club Student Association of Nursing Department