Clinical Trial Lead Resume Example Health Decisions

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

Oncology (Cervical Cancer)
Contraceptives
Neurology (Alzheimer's Disease)
Infectious Disease (Influenza)

Women's Health
Hormone Replacement
Device (HPV Diagnostic, Colon Cancer Diagnostic, Contraceptives)

Experience

Health DecisionsDurham, NCClinical 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

Health DecisionsDurham, NCSenior 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

Health DecisionsDurham, NCClinical Research Associate II08/2007 to 09/2010

Health DecisionsDurham, NCClinical Research Associate I08/2006 to 08/2007

Health DecisionsDurham, NCIn-House Clinical Research Associate02/2006 to 08/2006

Health DecisionsDurham, NCClinical 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

Lineberger Comprehensive Cancer CenterChapel Hill, NCResearch 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, Winston Salem, NC

Bachelor of Science:Biology2002Wake Forest University, Winston Salem, NC

Skills

Proficient with Microsoft Office Programs including Word, Excel, PowerPoint
Team leader
Mentoring junior staff
Electronic data capture
Rudimentary Spanish

Resume Overview

Companies Worked For:

Health Decisions
Lineberger Comprehensive Cancer Center

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

Clinical Trial Lead Resume Example

Resume Score: 90%

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