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Project Manager- Clinical Research/Trials management/ Regulatory comp

Location:
San Mateo, California, 94404, United States
Posted:
March 01, 2011

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ZEINA BABETTY, Ph.D.

kwwoh6@r.postjobfree.com

*** ****** **, *** **, Foster city, 94404

Cell: 650 *** ****

SUMMARY

** ***** ********** ** *&D, scientific training/teaching and project management. Outstandingly proactive,and excellent communicator with many people in various levels of academic and industry environments.

Multidisciplinary scientific background: A demonstrated outstanding knowledge of research terminology, biological, medical along with engineering principles.

Strong teaching experience: Developed scientific curricula, along with Masters level courses in both Sciences and Engineering Faculties. (Please, refer to relevant teaching job for more details)

Clinical Research experience: Certified as a Clinical Research Professional (SOCRA)

o Managed multisite clinical trials in Pancreas Cancer at UCSF, responsibilities included but not limited to:

Ensuring compliance of trials conduct: designing and completing CRFs, training staff, supervising and leading subsites, overseeing data submission, ensuring proper safety data is collected and reported to IRB, resolving compliance issues, with study sponsor, FDA and IRB. Being the point person, coordinating audits, working with the DSMB to ensure effective monitoring, and maintain adherence to protocol and local as well as federal guidelines, develop action plans and following up. Being the study/project manager communicating regularly with PIs, subPIs, nurses, FDA, sponsors and IRB addressing non-compliance issues.

Managing Data quality control: Abstracting and interpreting clinical data for population of internal and shared electronic databases. Assisting investigators with data compilation for analysis. Performing data quality control for multisites trials. Completing study audit and following up with corrective actions. Performing periodic quality reviews, generating data reports and developing corrective actions and measures to assure adherence to regulatory guidelines.

Pursuing regulatory compliance:Identifying and maintaining regulatory processes for research projects (new and ongoing) and interfacing with Program Investigators, clinical trial sponsors and local and federal agencies; preparing modified protocols and consent for approval from regulatory committees, preparing renewal submissions, tracking document study activities, providing assistance to staff and ensuring proper consent form distribution, meeting all deadlines. Taking the responsibility of communicating with IRB members to resolve compliance issues and communicating regularly with PI and sponsors on these matters.

Biomedical Research experience:

o Conducted several innovative in vivo studies in animals in many areas of research “Vascular Biology and Biomechanics”, coordinating research, communicating between different departments. (please refer to academic experience below)

Management experience: Led many projects in multidisciplinary teams with flexibility in handling multiple priorities in a fast-paced environment. Collaborated with many departments ensuring effective training. Served as a liaison between different departments and maintained many relationships to meet work goals.

Published and Presented in many journals and conferences :

o Archives of Surgery, July, 1998, Vol. 133, No. 7, pp.727-734

o Journal of The American College of Surgeons, Chicago, U.S.A April Issue, 1998,Vol. 186, No.4, pp.485-489.

o Proceedings of the 1998 2nd International Biomedical Engineering Days, Istanbul, Turkey.

o BED-Vol. 50, 2001 Bioengineering Conference, ASME 2001, pp. 397-398, Snowbird, Utah, U.S.A.

INDUSTRY EXPERIENCE

Project Manager “Clinical Research” Sept 2008- Nov 2010

UCSF, School of Medicine, Hem/Onc. Helen Diller Comprehensive Cancer Center, Pancreas Cancer Program

Collaborated with Cancer Center Core staff and outside institutions on complex multicentered studies., managing the conduct of the trials from concept to completion, performing different tasks: site coordination, data management, regulatory compliance

Abstracted and interpreted clinical Data for populations on internal and shared electronic databases, detailing the care and treatment of patients on therapeutic and non-therapeutic studies; requires understanding of topic and ability to decipher data from various unstructured sources to defined annotation fields.

Resolved data flow and data quality issues, worked with other clinical staff and IT to streamline the transition of information from Velos to Oncore, assisting the transition implementation team

Assisted investigators with data compilation for analysis, abstracts, posters and other publications.

Worked independently to identify regulatory needs on hearing about a trial, propose and carry out a plan of action for drafting, reviewing and completing regulatory requirements for sponsor, FDA and UCSF.

Assisted in general grant and development support to the program, including collecting and tracking various Data sources for program management: reviewing medical records to gather information on tissue samples from the last 10 years, assisting other departments in clinical data extraction, obtaining tissue specimens, and coordinating to provide storage of these samples.

Preclinical Services Coordinator Jan- Jun 2008

LyChron LCC. A Biomedical Research Organization

Assisted with writing ARC “Animal Research Committee” Documents and submitting to review process from the start until the final approval

Was responsible of tracking the approved documents and sending weekly updates to accounting

Organized the ARC Meetings and the semiannual review audits, coordinating between members and composing the Full committee Review drafting minutes, ensuring compliance with laws and regulations

Training Coordinator 2004-2006

Ciba Vision Sterile Manufacturing, A Novartis Co. Mississauga, ON.

Designed and implemented an effective training program, customizing it to the company’s needs to meet regulatory compliance goals.

Led a team to drive compliance through a network of training groups that focused on: addressing the issues behind the lack of training and developing/maintaining employee specific training schedules/plans.

Ensured goals are accurate and aligned with department, site and business goals.

ACADEMIC EXPERIENCE

Lecturer Fall, Spring (1999-2000), Spring (2002-2003) & Fall (2003-2004)

Dept. of Electrical Engineering, Biomedical, Balamand University, Tripoli, Lebanon

Launched/developed and taught the Masters level courses in Biomedical Eng.: “medical Instrumentation” and “Biomechanics”

Developped Physiology courses for Engineers and Biology course.

Was often invited as a guest lecturer at the American University of Beirut in many science-related topics.

Was a speaker at multiple conferences on different research topics

Postdoctoral Fellow 2001-2002

Emory University, Atlanta, GA, U.S.A

Project: Vascular Remodelling (cont’d: arteries mechanical properties and MMPs)

Studied the mechanical properties of carotid arteries in WT, ApoE and MMP-9 (KO) mice.

Investigated the problem of Atherosclerosis not only from the medical but also from the engineering perspective, conducting different types of experiments: molecular and mechanical tests.

Wrote research grants to the American Heart Association, successfully interpreted data in both the engineering the medical languages and presented findings in conferences.

Postdoctoral Fellow 2000-2001

University of Vermont, Burlington, VT, U.S.A.

Project: Vascular Remodelling: Effect of Hemodynamics (pressure, flow)

Investigated the effect of increased transmural pressure and pulsatile flow upon vascular remodelling in living tissue.

Conducted experiments: Molecular and mechanical tests.

The work was presented at: BED-Vol 50, 2001 Bioengineering conference, ASME, Snowbird, Utah, U.S.A.

EDUCATION

Ph.D. - Biomedical Engineering: GPA: 3.92/4.00 1998

Boğaziçi University (previously Robert College: the American University), Istanbul, Turkey

Studied the mechanical and biological performance of new knot configurations in abdominal surgery, as compared with conventional sliding knots. Developped different aspects of the research in a Ph.D. thesis that analyzed medical problems in surgery through performing quantitative studies in Mechanical Engineering.

Masters of Science (M.Sc.) - in Biomedical Engineering 1993

Boğaziçi University (previously Robert College: the American University), Istanbul, Turkey

American University of Beirut, Beirut, Lebanon 1990

Bachelor of Science (B.Sc.) – Biology.

SKILLS

Computer: expert in Microsoft office, word, excel, powerpoint, lotus notes

Certified as a Clinical Research Professional (SOCRA)

Familiar with GMPs, certified in GMP Course, the Academy of Applied Pharmaceutical Sciences

Familiar with GLPS and GCPs and well trained in Guidelines governing Clinical Research

Excellent written, verbal communication and interpersonal skills

Languages: Arabic, French, English and Turkish



Contact this candidate