Clinical Scientist/Clinical Research Manager
Resume:
Bohang Bonnie Chen, MD
PhD (candidate)
** ***** *****, *****, ** 07712
*******@*****.***
SUMMARY
• Excellent oral communication skills with 5 years of medical/scientific writing experience.
• Seven years of clinical research experiences with team leadership and problem-solving capabilities.
• Participate in all aspects of clinical development and study management.
• Responsible for protocol development, study design, management and implementation
• Expertise at medical and safety data review, data management, SAE and Adverse Events evaluation and reconciliation.
• Therapeutic areas: Oncology, cardiovascular, endocrinology, neurosurgery, neurology, psychiatry, urology, woman health and Immunology.
EMPLOYMENT HISTORY
Novartis, Florham Park, NJ
Clinical Scientist II/Clinical Research Manager (contract) 08/2009-present
• Draft study synopses and protocol, obtain key opinions from KOL, act as a liaison between project team and KOL. Compose abstracts, manuscripts and clinical findings
• Develop certain sections of Investigator’s Brochure, Briefing Book, IND annual book, IND and clinical study report.
• Responsible for all operational activities of clinical trial under the leadership of clinical trail director. Support all scientific aspects of clinical trial(s) as assigned
• Serve as a primary contact for the sites, answer clinical trial related questions.
• Select and manage CRO to ensure adherence to scope of work, budget, and timelines
• Monitor and track clinical trial progress as appropriate, reviewing monitoring reports.
• Act as clinical trial leader in managing of patient data review including clinical data cleaning up, data query generation, data summarization and data analysis.
• Responsible for quality control of SAE reports and narratives, revising and finalizing the narratives, evaluate adverse events and perform SAE reconciliation.
• Review patient profile to monitor protocol deviation, generate protocol deviation listing.
• Prepare training materials and clinical trial related presentations
• Create monitoring plan and informed consent, provide input on CRF design.
• Therapeutic area: Oncology
Merck, Kenilworth, NJ 06/2007- 06/2008
Clinical Scientist (contract)
• Worked as a partner to the Project Physician/Director; contributed in the development of clinical protocols including design, writing, reviewing, finalization, amending and implement.
• Assisted Project Physician/Director to interface with project team members including: Clinical operations, Data management, Statistics, Drug safety, regulatory and project management.
• Contributed in the development of Strategy Development Plan, Pre-IND Meeting Briefing Book, investigator brochure and internal documents
• Developed operational contingency plans and trigger points with clinical project manager and project physician.
• Took necessary action to prevent or address problems regarding timelines, budget, resources and quality, provided input/guidance on both scientific and operational related study issues.
• Provided key opinions in the vendor and CRO selection, managed CRO, conducted sponsor and CRO meeting, tracked clinical trial progress.
• Conducted medical review and summarized patients’ Lab results, participated in study data analysis and SAE reconciliation, had responsibility to initiate, revise and complete all SAE narratives of two clinical trials.
• Functioned as a liaison for clinical programs, responsible for KOL program development, communicated with KOL nationally and internationally to obtained KOL’s opinions; organized advisory board meeting for KOLs.
• Searched and communicated with potential investigator globally to identify the investigators/sites.
• Provided trial related references, source documents, health authority responses to support the clinical trial. Responsible for the literature search, prepared the presentation slides
• Therapeutic area include: Neurology, Psychiatry, Oncology and Urology
Ortho-Clinical Diagnostics, a J&J Company, Raritan, NJ 10/2006 – 06/2007
Clinical Scientist(contract)
• Contributed to the development of clinical study protocol, created informed consent, and assisted in CRF design.
• Developed clinical project management plan, monitoring plan.
• Prepared clinical study training material and presentation slides for kick-off and investigator meetings.
• Worked as an integrated member of the clinical team in building, executing, and managing clinical trials.
• Provided guidance, clinical trial management expertise, and direction to monitors, clinical research associate and CRO.
• Managed, tracked and troubleshoot as necessary for assigned project or related studies.
• Conducted international clinical trials. Participated in the selection of investigators, reviewed and approved investigator sites,.
• Planed, coordinated, organized and conducted investigator meeting.
• Facilitated regulatory submission and communications by working with appropriate team members during the submission process.
• Answered questions from sites and monitors regarding trial conduction.
• Managed and cooperated with CRO to conducting monitoring, perform monitoring as necessary, reviewed and approved the monitoring reports.
• Searched and provided scientific references, reviewed papers and abstracts, prepared scientific documents
• Therapeutic area included: Woman Health Care, Cardiovascular, Diabetes.
Clinpro, Inc., Bound Brook, New Jersey 06/2006 – 09/2006
Clinical Project Manager
• Contributed to the development of study protocols and other key study documents.
• Ensured adherence to responsibilities assigned to ClinPro by contract with the sponsor.
• Developed the Project Plan and Project Tracking/Communications Plan for assigned projects.
• Participated in the development and review of study-related documents (e.g., monitoring plans, informed consent documents, CRF, monitoring tools).
• Organized weekly/monthly status meetings and teleconferences with project team and Sponsor.
• Assisted in the development of solutions to all issues relevant to study conduct, project conduct, resource application, and internal management; developed study timelines; tracked budgets, overall project status; oversaw the participation of investigator sites.
• Assisted in training and development of junior clinical personnel.
• Therapeutic area included: Oncology, Diabetes
Integra LifeSciences Corporation, Plainsboro, New Jersey 03/2005 – 05/2006
Senior Clinical Research Associate
• Developed clinical trial protocol independently, created informed consent and case report form, reviewed clinical study reports, adverse event reports, documents and publication (abstracts/manuscripts), provided literature review references and prepared scientific documents
• Participated in initiation, development and implementation of a pivotal clinical trial on spinal surgery with new medical device.
• Planed, managed, and ensured successful completion of routine to complex clinical studies.
• Assisted Clinical Affairs Director in the implementation and execution of single and multi-center clinical trials, ensured studies were conducted, recorded and reported in accordance with the protocol, SOP, GCP and the applicable regulatory requirements., maintained study schedules and resource needs.
• Participated in the selection of investigators and study sites, negotiated the clinical agreement and participated in management of budget, planed and organized meetings, made timelines and interacted with investigators and study site staff.
• Functioned as a liaison for clinical affairs department, VP and director.
• Worked collaboratively with CROs to conduct monitor activities such as pre-qualify visit, initiation, monitoring and close out, represent the company at investigational site.
• Served as Clinical Affairs Department representative on assigned teams, contributed in pre-clinical testing, prototype development, hazard and risk analysis of new products.
• Interacted daily with appropriate individuals to support and maintain the clinical investigation.
• Drafted version of Clinical Affairs Standard Operating Procedure (SOP), assisted in preparation and completion of documents for FDA submission.
• Therapeutic area included: Neurosurgery, Orthopedic Surgery, and General surgery
Kriger Research Center, Inc. (CRO) 06/2004 - 02/2005
Clinical Research Associate
• Assisted in the preparation of clinical trial protocol, investigator’s brochure, annual clinical study report, designed Case Report Form (CRF), and created Informed Consent.
• Collected, processed, and reviewed case report form, monitored adverse event reporting compliance, facilitate the Serious Adverse Event reporting process, review clinical data and develop data listing.
• Responsible for study file maintenance.
• Therapeutic areas included: Diabetes, Oncology, and Cardiovascular System.
Monmouth Medical Center, Long Branch, New Jersey 07/2001 – 08/2002
Resident in Radiology
• Worked as physician to prepare and perform radiology procedures through indirect contact with patients, trained to read radiographs of all basic diseases and provide reports.
• Had thorough knowledge of various diseases in different medical field, use x-ray (including CT), ultrasound, magnetic fields, unclear scans, PET scans and other forms of diagnostic tools to make diagnoses.
Long Island Jewish Medical Center, New Hyde Park, New York 07/1998 – 06/2001
Resident in General Surgery and Nuclear Medicine
• Worked as physician to handle primary care, diagnose and treat disease and injuries, report clinical cases and present on daily bases.
• Prepared patients for nuclear medicine procedures handled both adult and pediatric cases, intensively trained in interpreting and presenting test results.
Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois 06/1996 – 06/1998
Clinical Research Associate, Department of Anesthesiology
• Participated in Phase III and Phase IV studies.
• Had responsibilities to write protocol and study report, processed data analyzing and supervised the junior colleagues.
• Handled clinical trial documents and kept files.
• Ensured clinical trial was conducted according to GCP/ICH guideline.
• Participated platelet function study in vitro by using variety of reagents, which affect platelet function by different mechanisms, to monitor platelet aggregation role in coagulation system.
• Therapeutic Area: Anesthesiology, Cardiology, Hematology
Rush Medical College, Chicago, Illinois 10/1994 – 02/1995
Research Assistant, Department of Anatomy
• Specialized in clinical research by studying cytokine stimulation of megakarycytopoisis and platelet membrane receptor for adhesion protein; performed cell culture, protein purification, gel electrophoresis and organized laboratory experiments and supervised technicians.
Rush University, Chicago, Illinois 06/1992 – 09/1994
Ph.D. Student, Department of Immunology
• Focused on drug study on animal models (Pre-Clinical Studies) by monitoring the effect of Leflunomide on rat Cardiac Allograft and Xenograft transplant models; observing transplantation rejection and the inhibitory effect of Leflunomide on immune rejection.
• Wrote experimental protocol, set up and designed experiment, analyzed and managed the data, and wrote and presented report.
Tianjin First Central Hospital, P. R. China 07/1988 – 02/1992
Resident in Critical Care Medicine
• Developed clinical skill and judgment to handle the acute and critical illness, especially respiratory and renal failure cases.
EDUCATION
Rush University, Chicago, Illinois
Ph.D. Student (all except dissertation defense), Major: Immunology & Microbiology
Tianjin Medical University, Tianjin, P. R. China
M.D. Major: Medicine
Obtained ECFMG CERTIFICATE of USA in 1996, followed by four year residency training in USA
Nankai University, Tianjin, P. R. China
B.S. Major: Pre-medicine (Biology and Chemistry)
POST DOCTORAL TRAINING
Monmouth Medical Center, Long Branch, New Jersey 07/2001 – 08/2002
Resident in Radiology
Long Island Jewish Medical Center, New Hyde Park, New York 07/1998 – 06/2001
Resident in General Surgery and Nuclear Medicine
Graduated from nuclear medicine program in 2000
CERTIFICATE
ECFMG CERTIFICATE obtained in 1996
CERTIFICATE: Clinical Trial Monitoring and Research site Coordination, the ICH and GCP Guideline. Obtained in 2004
CERTIFICATE: Good Clinical Practice for Medical Device. Obtained in 2005
CERTIFICATE: Comprehensive Monitoring for Medical Devices. Obtained in 2005
CERTIFICATE: Effective Medical Writing. Obtained in 2005
CERTIFICATE: Statistic Concepts for Non-Statistician. Obtained in 2006
HONORS/AWARDS
Rush University, Chicago, Illinois, Scholarship two years
Tianjin Medical College, Tianjin, P. R. China, two year outstanding student.
Nankai University, Tianjin, P. R. China, three year outstanding student.
PUBLICATION AND PAPER
B. Chen, Clinical Trial Protocol “A Controlled, Randomized, Comparison, Blind Evaluations of Integra NPH Low Flow Shunt In Treatment Of Normal Pressure Hydrocephalus” May, 2005
J. N. Rini, B. Chen, “FDG uptake in the anterior mediastinum: Physiology thymic uptake or disease”, Clinical Positron Imaging, Vol 3, No 3, P 115-125 Poster on 47th Annual Meeting of the Society of Nuclear Medicine
B. Chen, M. B. Tomas, C. J. Palestro, “The effect of Morphine on the positive predictive value of cholescintigraphy “.
R. McCarthy, B. Chen. “Comparison of analgesic response to intrathecal analgesic administered via pe-10 and 32- gauge polyurethane intrathecal catheters in the rats”, Anesthesia and Analgesia, 1998; 86; S288
R. McCarthy, B. Chen, “Platelet integrin inhibition with c7E3 enhance the correlation between platelet aggregrometry and thromboelastographic (TEG) MA values”, Anesthesia and Analgesia, 1998; 86; S219
Dissertation Proposal: B. Chen, “The effect of Leflunomide on Cardiac allograft and xenograft rejection”
B. Chen, “Platelet aggregability in patients with ischemic cerebral disease” Tianjin Medicine Jounal, 1992
B. Chen, “Graves disease’s autoinmmune antibody production, receptor and bioloprocess”, Chinese Journal of Overseas Medicine: Endocrine, 1987
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