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临床监查员CRA求职英文简历模版

XXXXX

DOB: MMM.YYYY Gender: Male

Native place: XXXXX city, XXXXX Province

Major: Clinical Medicine & Molecular Oncology

Phone: 139XXXXXXXX

Email: XXXXXXXX

Objective

Senior CRA or CRA II (located in Shanghai)

Summary

Certified CRA of ACRP, March 2011~May 31, 2013;

More than two years experiences as a Clinical Research Associate;

In-depth knowledge of Helsinki Declaration, ICH-GCP Guidelines and SOPs;

Self-study of FDA CFR online;

Therapeutic areas include cancer, endocrine and cardiovascular diseases;

Good understanding of medical terminology;

Familiarity with EDC, IVRS/IWRS and central laboratory procedures;

Excellent interpersonal skills and fast prioritization of tasks;

Strong sense of self-discipline;

Good spirit of team work;

Fluent in American English and Mandarin;

Enjoy travelling.

Education

2005~2008, Master; Biomedical researches on Molecular Oncology; Fudan University, Shanghai, China

2000~2005, Bachelor; Clinical Medicine; University of South China

Work Experience

I. Mar/2011-June/2011, Research Assistant at Buck Institute for Research on Aging

Job Description: Assist in the design, preparation, implementation of experiments, and analysis of the results to explore the compounds that can extend lifespan of animal models and their corresponding molecular mechanisms, as well as to find new strategies for the treatment of neuron degenerative diseases such as Alzheimer’s disease and Parkinson’s disease; Acquired a well understanding of American culture and improved communication skills in English through this job.

II. Sep/2010-Mar/2011, Member of Association of Clinical Research Professional (ACRP)

(1) Systematically learning of ICH-E6, ICH-E8, ICH-E2A and ACRP recommended documents, such as Guide to Clinical Trials;

(2) Passed the examination of Certified Clinical Research Associate (CCRA);

(3) Study the clinical trial regulations of Food and Drug Administration (FDA);

(4) Involved in the discussion of monitoring and management of clinical trials in the e-Forum of ACRP, built the knowledge on the status quo of clinical trial industry in US.

III. Apr/2009-Aug/2010, Contract CRA in Omnicare Clinical Research (China), based in Boehringer-Ingelheim (Shanghai)

Main Responsibilities:

(1) Select appropriate sites to conduct clinical trials;

(2) Negotiate with principal investigators to conclude clinical trial contracts;

(3) Prepare IRB/IEC submission documents;

(4) Conduct initiation meeting to start a trial within required timeline;

(5) Perform periodic monitoring visits to discuss recruitment with investigators, to verify trial data against source documents, to coordinate with the resolution of queries, to facilitate the report of SAE, to check records regarding investigational products, to assist with the arrangement of essential documents, and ultimately, to protect the safety, rights and well-being of subjects and to keep high quality as well as good progress of clinical trials;

(6) Make close out visits according to SOP, ICH-GCP and applicable regulations;

(7) Liaison between site and sponsor for other logistic affairs;

(8) Write relevant reports according to SOP.

Achievements:

(1) Responsible for monitoring 2 trials, including 7 sites and 71 ongoing subjects simultaneously; this was the highest workload among all CRAs in Boehringer-Ingelheim. Moreover, the recruitment was faster than most colleagues’sites, RDC verification rate was kept near 80%, and all trial related documents were filed well in sites;

(2) 4 subjects were recruited within one month after initiation visit of a global phase III trial. This recruitment rate was 7 times higher than the average recruitment speed that was 2 subjects every 4 months;

(3) 43 eligible subjects were enrolled within two months for a global phase IV trial. This timeline was more than two months ahead of global plan;

(4) 25 subjects were recruited for a phase I clinical trial within one month, all EDC queries were resolved on time, all essential documents were filed well and samples were sent to UK within schedule.

IV.Jul/2008-Mar/2009, CRA in Shanghai Zhangjiang Biotechnology Co. Ltd.

Main jobs and accomplishments:

(1) Involved in the monitoring of one phase I and one phase III trial of anti-tumor drugs;

(2) Presided over one initiating meeting of a phase III trial. Highly praised by investigators for outstanding presentation skills and close attention to details; (3) Periodic monitoring visits for 6 sites. Enhance the recruitment from 12 subjects per month to 16;

(4) Wrote research summary for investigational products. Acquired a broad knowledge on anti-tumor products;

(5) Assist in the organization of an investigators’ meeting;

(6) Edited slides for one investigators’ meeting.

Trainee Experience

(1) Apr/2010, CRA Essential Skills Training Courses provided by Senior Training Director Mr. Iain Searle of Omnicare Clinical Research. Main topics include the responsibilities and procedures about four types of monitoring visits: pre-trial visit, initiation visit, periodic monitoring visit and close out visit;

(2) May/2009, RDC Onsite Classroom Training for CRAs in Boehringer-Ingelheim;

(3) May/2008-Oct/2008, International CRA Training Courses offered by Jack Xu, who is the former Medical Director of Quintiles Medical Development (Shanghai).