clinical research associate resume example with 14+ years of experience
Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA94105
:
Professional Summary
Self-motivated, innovative and goal-oriented clinical research professional who has demonstrated working history of regulatory affairs, clinical operations and project management in multiple therapeutic areas such as solid tumors, hematologic malignancy, infectious diseases and neurological diseases. Four-year experience with pharmaceutical company in oncology drug clinical development, regulatory affairs and project management; and four-year experience with global clinical CROs in clinical monitoring and operation, studies/sites management and oversight of external vendors. Proven and recognized great team player and excellent communication skills.
Education
University of California, San DIego La Jolla, CAExpected in 2015 ā āProfessional Certificate:Clinical Trial Design and Administration - GPA:
University of WuerzburgWuerzburg, GermanyExpected in 2011 ā āPh.D.:Cell Biology & Oncology - GPA:
Sichuan Agricultural UniversityYa'an, ChinaExpected in 2005 ā āMaster of Science:Biochemistry & Molecular Biology - GPA:
Sichuan Agricultural UniversityYa'an, ChinaExpected in 2002 ā āBachelor of Science:Biotechnology - GPA:
Work History
Acutus Medical - Clinical Research Associate Seattle, WA, 05/2015 - Current
Executed study start-up, initiation, conduct and close-out activities for 7 studies, 40 sites, Global/US phase I-III trial;
Assessed the qualification of potential investigative sites, initiated clinical trials at investigative sites,instructed site personnel on the proper conduct of clinical trials, and closed clinical trials at investigative sites;
Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines;
Provided regular site status information to team members, trial management, and updates trial management tools;
Reviewed and verified accuracy of clinical trial data collected, either onsite or remotely;
Worked as primary contact point betweenĀ investigative sites and study team;
Managed external vendors;
Mentored junior level CRAs and serves as a resource for new employees;
Oversaw the quality and performance of junior CRAs;
Contributor and developer of all study documents including protocol, ICF template, CRFs and data collection tools, CRO oversight plan, site training materials;
Oversaw site management and monitoring vendor to complete feasibility and selection and start-up of 4 investigative sites for US and EU based phase I trials;
Identified, oversaw and collaborated with various external vendors to ensure compliance to protocol and GCP guidelines;
Supervised and trained Clinical Trial Assistants and Technical Assistants;
Assisted in organizing an investigator meeting;Ā
Conducted site visits to perform study initiation activities, interim monitoring visits, and study closure;
Liaised with investigative sites to address questions or problems related to clinical studies.
Duluxgroup - Research & Development Scientist Port Hedland, WA, 05/2008 - 06/2011
Provided subject matter expertise, introduced strategies to select and optimize therapeutic modalities and delivery platform choice for desired immune response, and designed studies to evaluate their performance;
Designed and performed both in vitro assays and in vivo animal studies which met cGLP requirements to evaluate and optimize therapeutic performance;
Applied immuno-assay/ELISA and flow cytometry/imaging techniques to investigate the function of immune cells from both animal models and clinical patient samples;
Managed collaborations with vendors, and frequently presented research findings and conclusions to colleagues and leadership teams;
Contributing member of project team to develop and validate molecular and cell-based assays for cancer companion diagnostics within clinical development program sponsored by Genelux Corporation;
Led project team to develop and validate "in vitro Liquid Biopsy/Circulating Tumor Cells (CTCs) Detection and Identification Assay" and transferred to current clinical trials program;
Utilized comprehensive techniques such as immuno-histochemistry, flow cytometry, in vitro/in vivo imaging, immuno-assay and qPCR to determine novel bio-markers which related to cancer immuno-therapeutic efficacy.
Institu Pasteur Of Shanghai - Project Manager/Lab Manager City, STATE, 06/2005 - 09/2007
Evaluated and negotiated with current and potential vendors and closely collaborate with experts in clinical operations and scientific areas;
Responsible for all laboratory routine issues and project planning and implementing;
Coordinated study monitoring, data valuation, protocol review, and accurate record-keeping as well as internal presentations;
Facilitated bio-safety program implementation, personnel training, regulatory compliance, facility upgrades and executive reporting.
Accomplishments
Honored with "Young Investigator Award" by Genelux Corporation due to my excellent contribution and achievements.
Honored with "Young Investigator Award" by American Association of Cancer Research (AACR) due to my excellent achievements.
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