October 1, 2009 An Introduction to Clinical Research
What is Clinical Research? <ul><li>Clinical research is the scientific evaluation of the safety and effectiveness of a new...
Clinical Research Center of Excellence <ul><li>Team of Consultants dedicated to sourcing, recruiting and </li></ul><ul><li...
The R&D Process                                                                                              
The Clinical Research Industry Sponsor CRO Electronic Application Provider Drug  Packaging IVRS Central Lab SMO Investigat...
Clinical Research Steps Study Design Study Initiation Study Enrollment Study Conduction Study Closeout Drug Accountability...
Clinical Trials – US Study Sites 12008 Total Studies  image -  www.clinicaltrials.gov 8/09
KSR Clinical Research – since 1996 <ul><li>Recruiting Clinical Research professionals since 1996 </li></ul><ul><ul><li>Cen...
Clinical Research Competencies <ul><li>Early phase to post marketing support </li></ul><ul><li>Industry Experience </li></...
CoE Recruiting Competencies <ul><li>Clinical Operations / Clinical Affairs </li></ul><ul><ul><li>Clinical Research Associa...
Clinical Research Expertise <ul><li>Therapeutic area experience   </li></ul><ul><ul><li>Oncology, Cardiovascular, Diabetes...
Upcoming SlideShare
Loading in...5
×

Ksr Clinical Introduction 2009 1

483
-1

Published on

Offers a brief overview of Kelly Scientifics Clinical Research Workforce Solutions group.

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
483
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Ksr Clinical Introduction 2009 1

  1. 1. October 1, 2009 An Introduction to Clinical Research
  2. 2. What is Clinical Research? <ul><li>Clinical research is the scientific evaluation of the safety and effectiveness of a new investigational medical treatment, medication or device in human volunteers. </li></ul>
  3. 3. Clinical Research Center of Excellence <ul><li>Team of Consultants dedicated to sourcing, recruiting and </li></ul><ul><li>placing clinical research, regulatory and medical affairs, data </li></ul><ul><li>management and biostatistics professionals with </li></ul><ul><li>pharmaceutical, biotechnology, and medical device companies, </li></ul><ul><li>as well as with research facilities, contract research and site </li></ul><ul><li>management organizations across the Americas. </li></ul>
  4. 4. The R&D Process                                                                                        
  5. 5. The Clinical Research Industry Sponsor CRO Electronic Application Provider Drug Packaging IVRS Central Lab SMO Investigator Study Participant
  6. 6. Clinical Research Steps Study Design Study Initiation Study Enrollment Study Conduction Study Closeout Drug Accountability Study Monitoring Adverse Events Reporting Data Collection
  7. 7. Clinical Trials – US Study Sites 12008 Total Studies image - www.clinicaltrials.gov 8/09
  8. 8. KSR Clinical Research – since 1996 <ul><li>Recruiting Clinical Research professionals since 1996 </li></ul><ul><ul><li>Center of Excellence (CoE) Re-launched August , 2008 </li></ul></ul><ul><li>Experienced management, seasoned recruiters </li></ul><ul><ul><li>Collectively, over 100 years recruiting, clinical research and HR consulting experience </li></ul></ul><ul><li>Workforce Augmentation (Temporary and Temporary-to-Hire), Executive Search, Project Management </li></ul><ul><li>Support Phase I to post marketing </li></ul><ul><li>Recruiters are position-focused (e.g. Regulatory Affairs, Clinical Affairs/Operations, Data Management) </li></ul><ul><li>Teams aligned geographically </li></ul><ul><li>Team approach </li></ul><ul><ul><li>Recruiter collaboration on flexible workforce </li></ul></ul><ul><ul><li>Select and submit most qualified candidates </li></ul></ul><ul><ul><li>Share candidate, salary and market intelligence to focus continuing sourcing efforts </li></ul></ul><ul><ul><li>Partner with Kelly’s network of local operations </li></ul></ul><ul><li>Proactive sourcing (i.e. recruiters source and network daily) via referral, networking, social media, niche partners, direct marketing and traditional methods </li></ul><ul><li>Active membership in Clinical Research & Professional Organizations including: DIA, ACRP, SoCRA, AMWA, AmStat and HBA </li></ul><ul><li>Customer Care team dedicated to service, follow-up and support </li></ul>
  9. 9. Clinical Research Competencies <ul><li>Early phase to post marketing support </li></ul><ul><li>Industry Experience </li></ul><ul><ul><li>Pharmaceutical </li></ul></ul><ul><ul><li>Medical and Diagnostic Device </li></ul></ul><ul><ul><li>Biotechnology </li></ul></ul><ul><ul><li>Contract (Clinical) Research Organizations </li></ul></ul><ul><ul><li>Site Management Organizations </li></ul></ul><ul><ul><li>Academic Research Institutions </li></ul></ul>
  10. 10. CoE Recruiting Competencies <ul><li>Clinical Operations / Clinical Affairs </li></ul><ul><ul><li>Clinical Research Associates (In-house and Regional) </li></ul></ul><ul><ul><li>Study, Site and Trial Managers </li></ul></ul><ul><ul><li>Project and Program Managers </li></ul></ul><ul><ul><li>Medical Directors </li></ul></ul><ul><li>Data Management, Statistical Programming and Biostatistics </li></ul><ul><ul><li>Global Librarians </li></ul></ul><ul><ul><li>Clinical Data Management Associates and Clinical Data Managers </li></ul></ul><ul><ul><li>Statistical Programmers (SAS, Oracle Clinical) </li></ul></ul><ul><ul><li>Biostatisticians, Managers and Directors of Biostatistics </li></ul></ul><ul><li>Medical and Regulatory Affairs </li></ul><ul><ul><li>Regulatory Affairs Associates and Managers </li></ul></ul><ul><ul><li>Drug and Product Safety Specialists </li></ul></ul><ul><ul><li>Pharmacovigilance and Safety Surveillance Specialists, Managers </li></ul></ul><ul><ul><li>GCP Auditors </li></ul></ul><ul><ul><li>Medical and Submissions Writers </li></ul></ul><ul><li>Additional: Clinical Supplies Managers, Contracts Managers, Business Development Managers </li></ul>
  11. 11. Clinical Research Expertise <ul><li>Therapeutic area experience </li></ul><ul><ul><li>Oncology, Cardiovascular, Diabetes/Endocrinology, Allergy/Rhinitis, Asthma/Pulmonary, CNS, Infectious Diseases, Vaccines, Immunology, Acute Care, etc. </li></ul></ul><ul><li>Device experience </li></ul><ul><ul><li>Cardiovascular (Rhythm Management, Atrial Fibrillation, Stent), Orthopedic implant, Neuromodulation, Imaging, Respiratory, Diabetes Diagnostic, Oncology Diagnostic, Ophthalmology, etc. </li></ul></ul>
  1. Gostou de algum slide específico?

    Recortar slides é uma maneira fácil de colecionar informações para acessar mais tarde.

×