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Premier Research - Senior Clinical Research Associate Resume Example

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Isaiah Edwards
  • XXX XXXXXXXX XXXXX, Neptune, NJ 07753
  • - XXXXXXXXXXXX
  • - XXXXXXXXXXXXX
Summary


Highly experienced clinical research professional with considerable experience within the CRO, Pharmaceutical and Biotech environment.  Key experiences are within Analgesia, Hepatic and Biliary Disorders, Immunology, Oncology, Fertility device, Psychiatry, PONV and Pulmonary/Respiratory.



Skills
  • Electronic Data Capture Proficiency - CTMS, Medidata/RAVE, Trial Master, Inform, Phase Forward and Oracle
  • Microsoft Office Proficiency: Excel, Word, PowerPoint and Outlook
  • Extensive experience conducting CRF review
  • Extensive experience with vendor invoices: CROs, labs and Investigational sites.
  • Trip Report Review and Writing - over 10 years
  • Trial Management - US and Global
  • Time Management
  • Site Monitoring experience
  • Contract Negotiation and Budgets
  • Excellent Communication and Interpersonal skills
  • Exceptional knowledge in ICH guidelines and GCP
  • Managerial skills
Experience
Senior Clinical Research Associate 09/2014 to 05/2015
Premier Research
  • Monitored and conducted on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites.
  • Identified and resolved vendor and client issues.
  • Completed and submitted monitor trip reports for review and finalization.
  • Reviewed eCRFs for protocol adherence, protocol violations/deviations and query resolution.
  • Created Excel reports for tracking protocol violations/deviations and queries.
  • Monitored with knowledge of quality/scope and budget parameters.
  • Escalated issues and feedback for the team.
  • Worked with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase.
  • Participated in Investigators' Meeting
  • Ensured adherence to study timeline and budget
  • Attended meetings as required
  • Performed additional duties and assignments, as requested
Clinical Research Associate II 07/2012 to 09/2014
INC Research
  • Monitored and conducted on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites.
  • Identified and resolved vendor and client issues.
  • Completed and submitted monitor trip reports for review and finalization.
  • Reviewed eCRFs for protocol adherence, protocol violations/deviations and query resolution.
  • Created Excel reports for tracking protocol violations/deviations and queries.
  • Monitored with knowledge of quality/scope and budget parameters.
  • Escalated issues and feedback for the team.
  • Worked with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase.
  • Participated in Investigators' Meeting
  • Ensured adherence to study timeline and budget
  • Attended meetings as required
  • Performed additional duties and assignments, as requested
  • Provided clinical and technical support for Clinical Research Associate (CRA I) and administrative staff.
Freelance Consultant 10/2011 to 03/2012
Gracian Research
  • Developed capabilities for company website for Phase I
  • Developed SOPs for Phase I
  • Operation and Procedure Pricing
  • Budget development 
  • Created Study Recruitment strategies.
Remote Clinical Research Associate (Contract - completed) 07/2008 to 02/2009
ReSearch Pharmaceutical Services (RPS) - CRO
  • Managed clinical trials for Phases II, IIb, and III, drug development programs.

  • Electronic Data Capture Proficiency

  • Microsoft Office Proficiency: Excel, Word, PowerPoint and Outlook

  • Reviewed and approved invoices for vendor and site payments.  

  • Reviewed and approved monitor trip reports, tracked ongoing issues and query resolution.

  • Escalating compliance and study issues to Study Director.

  • Identified and resolved vendor and client issues.

  • Reviewed eCRFs for protocol violations/deviations.

  • Interacted with data management, project management, global company departments and regulatory departments for all study updates.

  • Developed and updated strategic documents such as Recruitment Plans and Monitoring Guidelines.

  • Managed cross-functional project timelines, resource capacity vs. availability, and budget.

  • Drove the development and updates of strategic documents such as Recruitment and Trial Plans and Monitoring Guidelines.

  • Analyzed timeline, resource, and budget information in order to conduct scenario planning, contingency planning, risk assessment and management, problem solving, and decision-making.

  • Assumed full responsibility for managing specific aspects of the project, identified issues and facilitated problem solving, contingency planning and decision-making.

  • Conducted study site electronic case report form training, validation and site certification

Local Trial Manager (RPS Contractor - project completed) 06/2007 to 07/2008
Johnson and Johnson-PRD, L.L.C
  • Assumed full responsibility for managing specific aspects of the project, identified issues and facilitated problem-solving, contingency planning and decision-making. 
  • Reviewed and approved CRO, labs and site payments.
  • Management of Clinical Research Organizations.
  • Extensive experience in EDC systems: CTMS, Inform, Phase Forward, Medidata/RAVE and Trial Master.
  • Reviewed subject data for protocol adherence and violations/deviations.
  • Created and tracked all protocol violations/deviations, ongoing site/study issues and adverse events.
  • Managed performance of team members by setting expectations, monitoring performance, providing feedback and follow-up to Study Director.
Senior Clinical Project Specialist/CRA (Contract - completed) 06/2006 to 02/2007
Schering-Plough Research Institute
  • Reviewed eCRFs for protocol compliance and deviations.
  • Escalated all compliance and study issues to Study Director.
  • Electronic Data Capture Proficiency - CTMS, Inform, Phase Forward, Trial Master, Medidata/RAVE, Oracle.
  • Microsoft Office Proficiency - Excel, Word, PowerPoint, Outlook
  • Negotiated and finalized contracts with CROs, labs and sites.
  • Reviewed and approved invoices from CROs, labs and sites.
  • Developed and maintenance of study budget and timelines.
  • Oversaw the selection and management of external vendors.
  • Reviewed and approved monitor trip reports to identify trends/issues within the US requiring intervention.
  • Communicated effectively with internal and external sources.
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US
  • Identified and managed critical issues for the US by developing and updating plans for risk management and contingency
  • Oversaw all US regulatory, ethical and administrative submissions.
  • Supervised the process and provided guidelines and training to team members and investigators regarding US IND and ICH/GCP requirements Organized and managed meetings (i.e., Investigator Meetings, Monitor Workshops, and CRO training).
  • Ensured protocol adherence and consistency of study processes and procedures across all US investigational clinical sites. 
  • Prepared/managed US budgets/financial plans and forecasts.
  • Identify site issues and initiate correction plans based on monitoring report.
  • Communicated effectively with internal and external sources
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US.
  • Performed data analysis / review and reported 'top-line' results for departmental review.
Clinical Operations 09/2001 to 06/2006
Forest Laboratories

Job Title: Clinical Research Scientist II - Jan. 2005 - June 2006

  • Negotiated and finalized contracts with CROs, labs and sites.
  • Reviewed and approved invoices from CROs, labs and sites.
  • Developed and maintenance of study budget and timelines.
  • Oversaw the selection and management of external vendors.
  • Reviewed and approved monitor trip reports to identify trends/issues within the US requiring intervention.
  • Communicated effectively with internal and external sources
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US
  • Identified and managed critical issues for the US by developing and updating plans for risk management and contingency
  • Oversaw all US regulatory, ethical and administrative submissions
  • Supervised the process and provided guidelines and training to team members and investigators regarding US IND and ICH/GCP requirements Organized and managed meetings (i.e., Investigator Meetings, Monitor Workshops, and CRO training).
  • Ensured protocol adherence and consistency of study processes and procedures across all US investigational clinical sites.
  • Reviewed and approved monitoring reports to identify trends/issues within the US requiring intervention.
  • Prepared/managed US budgets/financial plans and forecasts using appropriate tools.
  • Oversaw the selection and management of external suppliers supporting the US Developed and implemented study start-up and closeout plans for US sites. Identify site issues and initiate correction plans based on monitoring report.
  • Reviewed eCRFs for protocol compliance and deviations.
  • Escalated all compliance and study issues to Study Director.
  • Electronic Data Capture Proficiency - CTMS, Inform, Phase Forward, Trial Master, Medidata/RAVE, Oracle.
  • Microsoft Office Proficiency - Excel, Word, PowerPoint, Outlook
  • Communicated effectively with internal and external sources
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US.
  • Identified and managed critical issues for the US by developing and updating plans for risk management and contingency.
  • Oversaw all US regulatory, ethical and administrative submissions.
  • Supervised the process and provided guidelines and training to team members and investigators regarding US IND and ICH/GCP requirements Organized and managed meetings (i.e., Investigator Meetings, Monitor Workshops, and CRO training).
  • Managed performance of team members by setting expectations, monitoring performance, providing feedback and following up, when appropriate, with Study Director.
  • Wrote Clinical Study Reports and narratives.
  • Performed data analysis / review and reported 'top-line' results for departmental review.
  • Trained new clinical research scientists.


Job Title: Clinical Trial Manager II - May 2002 - Dec. 2004

  • Assisted Study Director with design of study protocols and guidelines, Informed Consent, and CRF design
  • Performed Co-Site Monitoring when necessary
  • Negotiated and finalized contracts with CROs, labs and sites.
  • Reviewed and approved invoices from CROs, labs and sites.
  • Developed and maintenance of study budget and timelines.
  • Oversaw the selection and management of external vendors.
  • Reviewed and approved monitor trip reports to identify trends/issues within the US requiring intervention.
  • Communicated effectively with internal and external sources
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US
  • Identified and managed critical issues for the US by developing and updating plans for risk management and contingency
  • Oversaw all US regulatory, ethical and administrative submissions.
  • Supervised the process and provided guidelines and training to team members and investigators regarding US IND and ICH/GCP requirements Organized and managed meetings (i.e., Investigator Meetings, Monitor Workshops, and CRO training).
  • Ensured protocol adherence and consistency of study processes and procedures across all US investigational clinical sites.
  • Reviewed and approved monitoring reports to identify trends/issues within the US requiring intervention.
  • Prepared/managed US budgets/financial plans and forecasts using appropriate tools.
  • Oversaw the selection and management of external suppliers supporting the US Developed and implemented study start-up and closeout plans for US sites. Identify site issues and initiate correction plans based on monitoring report.
  • Reviewed eCRFs for protocol compliance and deviations.
  • Escalated all compliance and study issues to Study Director.
  • Electronic Data Capture Proficiency - CTMS, Inform, Phase Forward, Trial Master, Medidata/RAVE, Oracle.
  • Microsoft Office Proficiency - Excel, Word, PowerPoint, Outlook
  • Communicated effectively with internal and external sources
  • Conducted US program, protocol, and site feasibility, and determined study conduct success within the US.
  • Identified and managed critical issues for the US by developing and updating plans for risk management and contingency.
  • Oversaw all US regulatory, ethical and administrative submissions.
  • Supervised the process and provided guidelines and training to team members and investigators regarding US IND and ICH/GCP requirements Organized and managed meetings (i.e., Investigator Meetings, Monitor Workshops, and CRO training).
  • Managed performance of team members by setting expectations, monitoring performance, providing feedback and following up, when appropriate, with Study Director. 
  • Performed data analysis / review and reported 'top-line' results for departmental review.
  • Trained new clinical trial managers.

  • Job Title: Clinical Research Associate  - Sept. 2001-May 2002

  • Performed Site Initiation, Site monitoring, Drug accountability, and Site Close-out
  • Collection of regulatory documents, management of clinical supplies, contact with site personnel, and processing of clinical data and adverse events Reviewed study data and data listings for completeness, accuracy and protocol adherence
  • Prepared/tracked required documentation from sites Interacted with data management, project management, global company departments and regulatory departments for all study updates.
  • Monitored clinical trial sites, confirmed CRF reporting, tracked site reporting, protocol deviations and patient status.

  • Site Support Specialist/ In-House Clinical Research Associate 04/1999 to 06/2001
    PRA International, Inc

    Job Title: Site Support Specialist/ In-house CRA

    • Management of clinical trials from start-up to close-out activities.
    • Collection of regulatory documents, management of clinical supplies, contact with site personnel, and processing of clinical data and adverse events.
    • Reviewed study data and data listings for completeness, accuracy and protocol adherence.
    • Prepared/tracked required documentation from sites Interacted with data management, project management, global company departments and regulatory departments for all study updates.
    • Monitored clinical trial sites, confirmed CRF reporting, tracked site reporting, protocol deviations and patient status.
    • Forecasted and maintained adequate clinical supplies.
    • Identify and resolve vendor and site issues.
    • Review of CRFs for completeness and discrepancies.


    Job Title: Project Assistant II - Apr. 1999 - Aug. 2000

    • Maintained SAE database and processed all SAEs
    • Collected and reviewed regulatory documents for IRB submission

    • Tracked protocol deviations and subject enrollment


    Medical/Regulatory Affairs Associate 08/1997 to 03/1999
    VRG International, Inc
    • Maintained Medical and Regulatory Affairs study files.
    • Assisted with Regulatory IRB submissions.
    • Interacted with project team and clinical sites.
    • Reviewed essential documents for completeness and accuracy.
    • Maintained report and processed all external vendor and site invoices.
    • Assisted Medical Director with data review and listings.
    Education
    Certification- Quality Management: 2012 Rutgers University - East Brunswick, NJ
    Quality Management
    Certification - Project Management, 2011 Rutgers University - New Brunswick, NJ
    Project Management
    BA: Political Science, 1993 Morgan State University - Baltimore, MD
    Political Science
    Affiliations
    Member of:
    ACRP, 2003
    DIA, 2003
    Language
    French (basic), English
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    Resume Details

    This is a real resume for a Senior Clinical Research Associate in Neptune, New Jersey with experience working for such companies as Premier Research, Inc Research, Gracian Research. This is one of the hundreds of Senior Clinical Research Associate resumes available on our site for free. Use these resumes as templates to get help creating the best Senior Clinical Research Associate resume.

    Previous Companies:

    • Premier Research
    • INC Research
    • Gracian Research

    Previous Job Positions:

    • Senior Clinical Research Associate
    • Clinical Research Associate II
    • Freelance Consultant
    • Remote Clinical Research Associate
    • Local Trial Manager

    Schools:

    • Rutgers University
    • Morgan State University

    Level of Education:

    • Certification- Quality Management
    • BA

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