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study project manager resume example with 20+ years of experience

Jessica Claire
Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
Home: (555) 432-1000 - Cell: - resumesample@example.com - : - -
Professional Summary
Over 10 years of experience working in the Biomedical Research Industry, and six years of experience in the Clinical Research Industry. *Hands on experience in monitoring of clinical investigations, study initiation, study monitoring, recruitment of study subjects, study closeout procedures and writing study protocol *Key experiences are within Analgesia, Neurology, Oncology, Psychiatry, antiviral and Cardiovascular *Working knowledge of ICH GCP guidelines, clinical trial monitoring, investigative site coordination, knowledge and understanding of FDA regulations
Skill Highlights
  • Inform
  • Impact
  • Oracle
  • Medidata
  • Lotus Notes
  • CTMS
  • Microsoft Office Applications: Excel, Word, PowerPoint
Professional Experience
08/2012 to Present
Study Project Manager Rti International Cumberland, MD, US
  • Responsible for managing global Phase I-III trials.
  • Responsible for writing protocol, informed consent forms and developing recruitment material.
  • Responsible for reviewing clinical study summary reports.
  • Responsible for Contract Research Organization (CRO) selection and management.
  • Responsible for selection and training of investigator sites.
  • Responsible for developing and managing protocols.
  • Develop training materials for study team.
  • Manage study timelines and budgets.
  • Responsible for building and maintaining the investigator database for upcoming future studies.
  • Manage multiple vendors.
  • Responsible for reviewing data remotely.
08/2011 to 08/2012
Clinical Research Associate Drug Information Association Inc Sacramento, CA, US
  • Responsible for managing Phase I-III studies.
  • Managed daily activities in a variety of clinical trials.
  • Assisted senior staff in planning study conduct, designing case report forms (CRFs).
  • Responsible for Contract Research Organization (CRO) selection and management.
  • Responsible for selection and training of investigator sites.
  • Responsible for planning and running study meetings.
  • Responsible for writing study protocols, and monitoring plan.
  • Developed training materials for study team.
  • Ensured adherence to study timelines and budgets.
  • Responsible for building and maintaining the investigator database for upcoming future studies.
  • Responsible for keeping track of study drug inventory.
08/2007 to 04/2011
Regional Clinical Research Associate Glaukos Waltham, MA, US
  • Responsible for the monitoring of clinical trials designed to evaluate the safety and efficacy of new therapeutic agents and the scientific review and analysis of clinical data and the preparation of scientific documents.
  • Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.
  • Investigator site identification, Study start-up activities, evaluation and selection, including pre-study site visits and close-out visits.
  • Responsible for the initial submission to IRB (completing 1572s, FDFs, Site applications, CVs, lab manuals, ICFs, etc).
  • Scientifically monitored clinical studies, which includes the review of case report forms (CRFs) to ensure adherence to the protocol and consistency and scientific validity of the data.
  • Provided technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials.
  • Reviewed of Case Report Form to assist Data Management.
  • Directed the tracking of enrollment rates, receipt and review of completed CRFs and grant documentation to ensure the efficient execution of a clinical trial.
  • Developed training materials, as necessary, for study team.
  • Ensured adherence to study timelines and budgets.
09/2005 to 08/2007
Regional Clinical Research Associate Glaukos Aliso Viejo, CA, US
  • Performed and coordinated all aspects of clinical monitoring.
  • Created source documents for clinical trials.
  • Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity.
  • Scientifically monitored clinical studies, which includes the review of case report forms (CRFs) to ensure adherence to the protocol and consistency and scientific validity of the data.
08/2004 to 09/2005
Clinical Site Coordinator University Of Michigan Ann Arbor, MI, US
  • Directed and maintained overall operations of clinical trials (industry, investigator, FDA and NIH funded) from initial submission to approval by regulatory boards, subsequent recruitment of subjects for trials and conducting subject clinic visits.
  • Involved with Study start-up activities.
  • Responsible for initial submission to IRB (completing 1572s, lab manuals, ICFs, etc).
  • Created source documents for clinical trials.
  • Completion of Case Report Forms and reporting of serious adverse events to sponsor/IRB.
  • Coordination of monitor visits including verification and correction of Case Report Forms.
  • Review of patient medical history to verify patient eligibility for study participation.
  • Organizing of study files, photocopying, ordering, tracking and maintaining study supplies.
  • Utilized strong analytical and negotiating skills to maintain and improve enrollment of subjects in research protocol Responsible for financial aspects of clinical research trials.
  • Run real time RT-PCR assay.
10/1998 to 12/2005
Certified Pharmacy Technician Common Spirit Grand Island, NE, US
  • Greeted customers, inputs prescription information into the computer and fills prescriptions.
  • Called physicians to obtain refill information; answered calls from physicians and customers.
  • Resolved customer concerns and served as the pharmacy's cashier.
05/2000 to 05/2003
Research Support Specialist Cornell University Ithaca, NY, US
  • Performed senior lab technician duties that are devoted to cell biology, molecular biology and immunology research.
  • Run PCR, ELISA, DNA, gel Electrophoresis assays.
  • Organized and cleaned the laboratory.
Education and Training
Expected in 2002 to to
B.Sc: Biological Sciences
Chicago State University - Chicago, IL
GPA:
Biological Sciences
Expected in 2016 to to
M.Sc: Clinical Research Management
Drexel University - ,
GPA:
Clinical Research Management
Community Service
Skills
biology, budgets, cashier, clinical research, clinical study, clinical trials, CVs, Data Management, database, designing, DNA, documentation, ELISA, financial, Forms, immunology, interpretation, inventory, Lotus Notes, managing, meetings, Excel, exchange, Microsoft Office Applications, PowerPoint, Word, molecular biology, negotiating, Oracle, Organizing, patient safety, PCR, personnel, fills prescriptions, protocols, real time, recruitment, reporting, Research, RT-PCR, safety, scientific, technician, training materials

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Resume Overview

School Attended

  • Chicago State University
  • Drexel University

Job Titles Held:

  • Study Project Manager
  • Clinical Research Associate
  • Regional Clinical Research Associate
  • Regional Clinical Research Associate
  • Clinical Site Coordinator
  • Certified Pharmacy Technician
  • Research Support Specialist

Degrees

  • B.Sc
  • M.Sc

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