Manager Project

CHENYING BAO

Cellphone: 416-***-**** E-mail: abqgam@r.postjobfree.com

Address: ****-* ******* ****** **., North York, ON M2J 1L2

HIGHLIGHTS OF QUALIFICATIONS

B.Sc. in Pharmacy, M.Sc. in Molecular Genetics and CCRA certificate from ACRP3 years of solid experience in clinical research including monitoring on siteStrong knowledge of FDA, ICH-GCPExperienced in coordinating Phase I, III & IV and medical device clinical trials in various indications (including global studies)Experienced in site selection visit, initiation site visit, interim monitoring visit and close-out visitExperienced in preparing research protocols, consent forms, REB applications, amendments and renewals Familiar with eCRF (Inform and Medidata) and IVRS/IWRSGood understanding of cost estimate and resource allocation in clinical trialsProficient in Microsoft Word, PowerPoint, Excel, Outlook Detail-oriented with effective interpersonal and communication skills Ability to work independently and in a multidisciplinary team Proficient in both written and spoken English and Chinese (Mandarin)

Working experience

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PPD Sr. CRA 2010 – 2011Monitored investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification) Assessed investigational product through physical inventory and records reviewDocumented observations in reports and letters in a timely manner using approved business writing standardsEscalated observed deficiencies and issues to clinical management expeditiously, presented potential solutions and followed up all issues through to resolutionMaintained regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely mannerConducted monitoring tasks in accordance with the approved monitoring planParticipated in investigator meetings as necessaryIdentified potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sitesInitiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH-GCP obligations, making recommendations where warranted. Performed trial close out and retrieval of trial materialsManaged the essential documents, as required by local regulations and ICH-GCP, before, during and after a clinical trialProvided trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required Ensured study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)Facilitated effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contactsResponded to company, client and federal regulatory requirements/auditsMaintained & completed administrative tasks such as expense reports and timesheets in a timely mannerContributed to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team membersPerformed other project work as assigned

Tigermed Consulting Ltd. CRA~ Sr.CRA 2008 – 2010Coordinated phase I-IV clinical trials in various indicationsPerformed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devicesDocumented preparation: write clinical trial protocol, ICF, CRF, Subject’s Diary etc. and prepared the submission materials to ethic committeesConducted site visits to determine protocol and regulatory compliance, and prepared required documentationPerformed as a Lead CRA in assigned projectsDeveloped collaborative relationships with investigative sites and client company personnel

OTHER EXPERIENCE

Toronto General Hospital Volunteering Ongoing

Shanghai Shining Biotechnology Ltd. Manager (R & D Department) 2005 – 2007

Second Military Medical University Research Assistant 2000 – 2003

Education

2012 – 2013 Clinical Research Post Graduate Diploma Program, AAPS

2007 – 2008 Clinical Research Associate Certificate, McMaster University

2003 – 2005 M.Sc., Molecular Genetics, University of Leicester

1996 – 2000 B.Sc., Pharmacy, China Pharmaceutical University

CERTIFICATE

CCRA certificate issued by the ACRP

References available upon request

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