HELLO MY NAME IS… Stephanie Swords Research Program Manger – Office of Recruitment and Retention (ORR) Institute for Clinical and Translational Research (ICTR) Johns Hopkins University – School of Medicine 1820 Lancaster Street – Suite 300 Baltimore MD 21231 (410)-502-5673 sswords1@jhmi.edu TOPICS: - Career Options Educational Opportunities Certifications Training Opportunities JHU Career Progression CAREERS IN CLINICAL RESEARCH Government Study Coordinator Pharma Research Management Clinical Research CLINICAL RESEARCH CAREER PATH - Centered around being a participant of a study team - Gain greater responsibility as you gain more experience - With further education and training you can become a strong study team member with greater responsibilities RESEARCH MANAGEMENT - Can be part of a research team, but typically participant interaction is limited - More focused on education and training of others - responsible for others - Must stay on top of all changes in rules and regulations PHARMA - Working for a Pharmaceutical Company - Monitor, Study Development, Project Manager - Includes lots of travel - Home office and other perks - Loss of participant interaction GOVERNMENT - NIH Military Contractor Grant Writing & Project Management May include some participant interaction EDUCATION: - Getting a Degree Clinical Degrees Tuition Remission Benefits Clinical Research Specific Degrees outside of JHU GETTING A DEGREE If you don’t have one think about getting one… If you have one, think about getting another one… ACRP Discounted fees if applicant is a current member of ACRP ELIGIBILITY CATEGORIES – Option Associates or Bachelor’s degree (or higher) OR Registered Nurse (RN) 3,000 hours performing essential duties Detailed CV/resume AND Job Description Option Other, such as LPN, LVN, Medical Assistant, Lab Technician OR High School diploma 4,500 hours performing essential duties Detailed CV/Resume AND Job Description ACRP Clinical Research Education Programs The Academy considers applicants who have completed a clinical research education program that meets the following standards to have achieved a valid substitute for 1,500 hours of professional experience Acceptable programs must: - Be at least 216 contact hours in length AND - Cover content that substantially maps to the topics found on the current CRC Detailed Content Outline (DCO) AND - Be accredited by an accrediting agency recognized by the Council on Higher Education Accreditation (CHEA) A list of recognized accrediting agencies can be found from the CHEA website: www.chea.org/search/default.asp ACRP The CCRC® Examination is designed as a practice-based exam for individuals involved in the performance of the essential duties of a clinical research coordinator to assess proficiency of the five (5) core knowledge areas: Investigational Product Management Protocol Safety Trial Management Trial Oversight - ICH Guidelines (E2A, E6, E8, E9) - Declaration of Helsinki* (latest version) ACRP: - - Application Deadlines: July 31, 2012 (Late Applications accepted with late fee through August 14, 2012) 10 day testing window- Sept 6- 15, 2012 Approximately 600 testing centers internationally www.prometric.com/acrp ACRP: - Costs: Membership= $150 Baltimore/Washington Chapter Membership=$25 Application Fee= $115 (for members & non-members) Exam Fee= $347 members/$547 non-members Late Application Fee = $150 TRAINING: - Certificates Training, Workshops & Lectures JHU Training Programs and Classes Conferences CERTIFICATES: - JHSPH SOCI Certificate - http://www.jhsph.edu/academics/programs/certificates/program/50 Required courses: 390.676 Design of Clinical Studies (3 credits) 390.672 Quantitative Analysis of Clinical Data (3 credits) Students must also complete two of the following: 390.841 Database Design and Implementation in Clinical Research (2 credits) 390.673 Ethical and Regulatory Issues in Clinical Research (3 credits) 390.675 Outcomes and Effectiveness Research (3 credits) Contact: Cristina DeNardo gtpci@jhsph.edu TRAINING WORKSHOPS AND LECTURES: - ORR Lecture Series IJHN First Friday ICTR Community Engagement Two-week Intensive Course offered by ICTR Webinars RCTP - IJHN TRAINING WORKSHOPS AND LECTURES: - SOM Programs – Bringing the Science of Safety to Clinical Research PI & SC attend together -The workshop involves two sessions: Session 1: Tuesday, Sept 4, to 3:30 p.m – Tilghman Auditorium Session 2: Tuesday, Oct 9, to 3:30 p.m – Bunting Blaustein Cancer Building, Owens Auditorium http://www.hopkinsmedicine.org/institutional_review_board/about/training_requirements/upcoming_training.html JHU TRAINING: - Professional Development Courses http://tmod.jhu.edu/prof_dev/prof_dev.cfm - Login through Mylearning JHU TUITION REMISSION – PROFESSIONAL DEVELOPMENT http://benefits.jhu.edu/tuition/remission.cfm - There is no annual dollar limit or reduction of annual limits for non-credit professional development or personal enrichment courses You receive 100% remission if your department certifies the course is valuable for your professional development and your department is willing to pay if you not attend or cancel from the course with at least one week's notice CONFERENCES: - SoCRA - http://www.socra.org/html/SoCRA_Annual_Conference.htm ACRP - http://www.acrp2013.org/ MAGI - http://www.magiworld.org/events/2012W/  Model Agreements & Guidelines International  streamlining clinical research by standardizing best practices for clinical operations, business and regulatory compliance  Free Membership JHU CAREER PROGRESSION: - Staff members are eligible for a merit increase annually Merit increases are based on the staff member's performance during the prior year and the salary increase budget available within the department Performance is evaluated according to the current job description and accomplishments of goals, objectives, and/or special projects and assignments as described in the Personnel Policy Manual - A developmental increase may be granted to a staff member who has acquired increased skills and competencies in their current job This recognizes the staff member's increased value to the university and in the marketplace without reclassifying the staff member to another job - A market-based promotional increase may be awarded to a staff member who has made a meaningful job change to a new job with increased responsibilities and higher pay in the market - A contribution level promotional increase may be awarded to a staff member who makes a significant job change by moving to a job that has a higher contribution level and a higher salary range Read more information and examples of salary increases JHU CAREER PROGRESS: Title Data Assistant Research Program Assistant Research Program Assistant II Research Program Coordinator Research Program Supervisor Sr Research Program Coordinator Sr Research Program Supervisor Sr Research Program Coordinator II Research Manager Sr Research Manager Research Associate Role ACRO ACRO ACRO ACRO ACRO ACRP ACRP ACRP ACRP ACRP faculty Level 2 3 3 4 Range CA CB CC CD CE MB MC MC MD ME http://hrnt.jhu.edu/pay/salary_ranges.cfm ... sswords1@jhmi.edu TOPICS: - Career Options Educational Opportunities Certifications Training Opportunities JHU Career Progression CAREERS IN CLINICAL RESEARCH Government Study Coordinator Pharma Research... increases JHU CAREER PROGRESS: Title Data Assistant Research Program Assistant Research Program Assistant II Research Program Coordinator Research Program Supervisor Sr Research Program Coordinator. .. getting one… If you have one, think about getting another one… DEGREES - Easy justification for career promotion - Think about what degree might benefit you the most - Be sure you can handle taking