SoCRASoCRAThe Society of Clinical The Society of Clinical Research AssociatesResearch Associates

Kimberly B. Bradley, CCRPKimberly B. Bradley, CCRP

OverviewOverview

Background and GrowthBackground and Growth

MissionMission

CertificationCertification

Getting InvolvedGetting Involved

BackgroundBackgroundFounded and Incorporated in 1991Founded and Incorporated in 1991

First annual conference in 1992First annual conference in 1992

CCRP certifications began in 1995CCRP certifications began in 1995

““Quality Education, Peer Quality Education, Peer Recognition, Professional Recognition, Professional Certification” Certification”

Current MembershipCurrent Membership

11,350 members 11,350 members (as of December 31, (as of December 31, 2008)2008)

>6,687 are CCRP certified>6,687 are CCRP certified

41 countries 41 countries represented represented

Six continentsSix continents

53 Chapters53 Chapters

Mission StatementMission Statement

““The express aim of SoCRA is to The express aim of SoCRA is to provide training and continuing provide training and continuing education for clinical research education for clinical research professionals and to establish professionals and to establish and maintain an international and maintain an international

certification program for clinical certification program for clinical research professionals.”research professionals.”

Mission-Specific ActionsMission-Specific ActionsEstablishing educational Establishing educational programming and provide programming and provide continuing educationcontinuing education

Establishing an internationally Establishing an internationally recognized certification program, recognized certification program, andand

Fostering the professional Fostering the professional development and peer recognition development and peer recognition of Clinical Research Professionalsof Clinical Research Professionals

Clinical Research Clinical Research ProfessionalProfessional

Clinical investigator, sub-investigator, Clinical investigator, sub-investigator, clinical researcher, research nurse, clinical researcher, research nurse,

administrator, coordinator, administrator, coordinator, consultant, or educator in clinical consultant, or educator in clinical

trial management…involved in one trial management…involved in one or more aspects of clinical trials or more aspects of clinical trials

research…research…

Clinical Research Clinical Research ProfessionalProfessional

data collection, analysis, data collection, analysis,

oror monitoringmonitoring

case management of case management of protocol participantsprotocol participants

recruitment and recruitment and enrollment of human enrollment of human subjectssubjects

protection of subjects and protection of subjects and subjects’ rights through subjects’ rights through IRB relationsIRB relations

development of informed development of informed consentsconsents

preparation of adverse preparation of adverse event experience reportsevent experience reports

construction or monitoring construction or monitoring of case report formsof case report forms

maintenance of drug maintenance of drug accountability recordsaccountability records

grant and budget grant and budget developmentdevelopment

report preparationreport preparation

education of other health-education of other health-care professionals, patients care professionals, patients or families regarding or families regarding clinical trials clinical trials

protocol developmentprotocol development

program administrationprogram administration

research program auditresearch program audit

SoCRA MembershipSoCRA Membership

Open to any clinical research Open to any clinical research professionalprofessional

Do not have to be certified (or Do not have to be certified (or obtain certification) to be a obtain certification) to be a membermember

Local chapter membership Local chapter membership included automaticallyincluded automatically

Virginia MembershipVirginia Membership

159 members, 76 certified 159 members, 76 certified CCRPsCCRPs

7 VCU members certified CCRPs7 VCU members certified CCRPs

Certification—CCRPCertification—CCRP

SoCRA Membership SoCRA Membership (prior to or at time of (prior to or at time of exam application)exam application)

Eligibility requirementsEligibility requirements

Successfully pass CCRP ExamSuccessfully pass CCRP Exam

Re-certify every three yearsRe-certify every three yearsrecertification exam recertification exam

45 hours continuing education45 hours continuing education

Minimum ExperienceMinimum ExperienceTwo years of full time employment in Two years of full time employment in clinical research during last five years, clinical research during last five years, OROR

Degree in Clinical Research, with 1 year of Degree in Clinical Research, with 1 year of full time experience during the last two full time experience during the last two years,years, OROR

12 or more semester hours in a clinical 12 or more semester hours in a clinical research curriculum with a degree in a research curriculum with a degree in a related field and one year of experience related field and one year of experience during the past two years. during the past two years.

See exam application for details on degrees and information on qualification See exam application for details on degrees and information on qualification with part-time hours.with part-time hours.

Common QuestionsCommon Questions

Will I get a raise?!?!?!Will I get a raise?!?!?!

Will work pay for it?!?!?!Will work pay for it?!?!?!

Exam ExpenseExam ExpenseSoCRA Membership is $75 per SoCRA Membership is $75 per yearyearCertification exam is $195 Certification exam is $195 (member (member rate)rate)

Recertification is $100 Recertification is $100 (every three years)(every three years)

SCT (Society for Clinical Trials)SCT (Society for Clinical Trials)$110 annual membership; no certification available$110 annual membership; no certification available

ACRP (Association of Clinical Research Professionals)ACRP (Association of Clinical Research Professionals)$150 annual membership $150 annual membership $20-25 charge to join local chapter $20-25 charge to join local chapter $410 for certification exam (includes $100 application fee, $410 for certification exam (includes $100 application fee, member rate)member rate)

Benefits of CertificationBenefits of CertificationRaises are department specific and Raises are department specific and usually multi-factorialusually multi-factorial

Internationally recognizedInternationally recognized

Commitment to the field of researchCommitment to the field of research

Proof of knowledge and familiarity Proof of knowledge and familiarity with regulationswith regulations

Salary SurveySalary SurveyCCRP not directly correlated with CCRP not directly correlated with higher salaryhigher salary

only applies to newly certifiedonly applies to newly certified

CCRPs with three years or more of CCRPs with three years or more of certification make above average certification make above average salariessalaries

Higher incomes associated more Higher incomes associated more with education and years with education and years experienceexperience

Salary Survey FindingsSalary Survey Findings

““More involvement in More involvement in professional organizations, professional organizations,

including attending the SoCRA including attending the SoCRA annual conference and annual conference and education workshops, is education workshops, is associated with higher associated with higher

compensation.”compensation.”

Get InvolvedGet Involved

Step One: JOIN!Step One: JOIN!

““The secret of getting ahead The secret of getting ahead is getting started.”is getting started.”

–Sally Berger–Sally Berger

Get Involved!Get Involved!

Attend an Annual ConferenceAttend an Annual ConferenceSeptember 2009: Nashville, TNSeptember 2009: Nashville, TN

Gaylord Opryland HotelGaylord Opryland Hotel

Future Dates:Future Dates:September 2010: Dallas, TXSeptember 2010: Dallas, TX

September 2011: San Francisco, CASeptember 2011: San Francisco, CA

September 2012: Las Vegas (not finalized)September 2012: Las Vegas (not finalized)

Get InvolvedGet Involved

Attend Educational CoursesAttend Educational CoursesFDA Clinical Trial RequirementsFDA Clinical Trial Requirements

Clinical Site ManagementClinical Site Management

Device Research WorkshopDevice Research Workshop

Clinical Science CourseClinical Science Course

SOP Development and SOP Development and ImplementationImplementation

Monitoring WorkshopMonitoring Workshop

Get InvolvedGet Involved

Attend local chapter meetingsAttend local chapter meetingsMeet in conjunction with Meet in conjunction with department meetingsdepartment meetings

Sponsor SoCRA programming Sponsor SoCRA programming and certification testsand certification tests

Hold “mini” conferences for Hold “mini” conferences for localslocals

Get InvolvedGet Involved

Take the CCRP Exam Take the CCRP Exam

Speak at local and/or national Speak at local and/or national meetingsmeetings

Volunteer for committees or Volunteer for committees or Board membershipBoard membership

Always Changing…Always Changing…Research is a field of constant Research is a field of constant changechange

RegulationsRegulations

Clinical CareClinical Care

TechnologyTechnology

Education and involvement are Education and involvement are essentialessential for career movement for career movement and field advancementand field advancement

Finishing QuoteFinishing Quote

““If you want to accomplish anything If you want to accomplish anything in life, you can't just sit back and in life, you can't just sit back and hope it will happen. You've got to hope it will happen. You've got to

make it happen.”make it happen.” ––Chuck NorrisChuck Norris