Clinical Trial Lead Resume Example
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CLINICAL TRIAL LEAD
Summary
Creative clinical research professional with over 10 years of experience. Proven ability to manage multiple tasks while meeting challenging deadlines. Strong communication skills with involvement in all levels of relationship building, program development, and protocol implementation.
Therapeutic Experience
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Experience
Iqvia Holdings IncEl Centro , CAClinical Trial Lead 10/2012 to 08/2014
- Provide leadership in delivery of services to clients
- Ensure study team fulfilled their responsibilities in accordance with company policies, procedures, and SOPs
- Oversee monitoring report review, study training for clinical monitoring team, overall site and CRA metrics, site allocation and assignment
- Assist project management with resource and utilization assessments, timeline adherence, quality assurance, and financial adherence
- Act as secondary sponsor contact
- Act as a resource for protocol and process questions from clinical monitoring team members
- Ensure site and in-house monitoring occurs according to Monitoring Plan and study timelines
- Generate study documents
- Negotiate site budgets and contracts
- Serve as contact for investigative sites and outside vendors
- Maintain monitoring forecast
- Lead CRA meetings
- Provide mentoring and feedback on clinical team member performance
Inc Research IncJersey , GASenior Clinical Research Associate09/2010 to 10/2012
- Manage site activities with respect to study protocol compliance, data collection and submission, and general ICH/GCP compliance
- Instruct sites on study protocols and procedures
- Instruct sites on study data collections systems and product management systems
- Monitor sites in accordance with ICH and GCP guidelines, study protocol, and SOPs
- Act as point-of-contact for study site investigators and personnel
- Create study documents
- Monitor clinical trials to ensure sponsor and investigator obligations are being met and activities are compliant with applicable local regulatory requirements and ICH guidelines
- Conduct site visits to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies
- Prepare appropriate documented communication to site
- Complete trip report documentation
- Review trip reports
- Provide regular clinical status information to team members and project management
- Perform investigative site file reconciliation
- Perform source document verification, reviewed drug accountability and safety and documents deviations to protocol and regulations at investigative sites
- Review Serious Adverse Event (SAE) reporting for compliance with regulations/specifications
- Respond to requests from investigative sites and oversee site queries
Clinical Research ManagementSyracuse , NYClinical Research Associate II08/2007 to 09/2010
Cedars SinaiTorrance , CAClinical Research Associate I08/2006 to 08/2007
Arena PharmaceuticalsBridgewater , NJIn-House Clinical Research Associate02/2006 to 08/2006
Planet PharmaBaltimore , MDClinical Trial Assistant06/2005 to 02/2006
- Execute and maintain communications and documentation for clinical studies in compliance with applicable local regulatory requirements and ICH guidelines
- Maintain study communication tools including web-based study applications
- Coordinate shipping and tracking with all phases of clinical studies
- Provide regular clinical status information to team members and project management
- Create study documents
- Work closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff
- Perform regulatory file reconciliation and maintain central files
- Request any new or updated essential and non-essential documents
- Review essential documents for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements
Armstrong World Industries, Inc.Lancaster , PAResearch Technician08/2002 to 06/2005
- Oversee the collection and preparation of formalin-fixed paraffin embedded and snap frozen tumor and normal tissue samples
- Distribute, including shipping, and invoicing for collected tissue samples
- Organize and catalog collected samples using Access database
- Manage collection for 25 cancer and neo-adjuvant treatment research protocols involving carcinoma of breast, gastro-intestinal, gynecological, and other organ systems
- Prepare and analyze graphs and charts compiling tissue collection data using Access database and Excel
- Purchase supplies and interact with various lab suppliers
- Handle and process blood for various studies
- Prepare touch-prep slides
Education
Selected Classes in Ecology, Biology2004University of North Carolina, City, State
Bachelor of Science:Biology2002Wake Forest University, City, State
Skills
- Proficient with Microsoft Office Programs including Word, Excel, PowerPoint
- Team leader
- Mentoring junior staff
- Electronic data capture
- Rudimentary Spanish
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Resume Overview
School Attended
- University of North Carolina
- Wake Forest University
Job Titles Held:
- Clinical Trial Lead
- Senior Clinical Research Associate
- Clinical Research Associate II
- Clinical Research Associate I
- In-House Clinical Research Associate
- Clinical Trial Assistant
- Research Technician
Degrees
- Selected Classes in Ecology, Biology 2004
Bachelor of Science : Biology 2002
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