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Study Coordinator Career Advancement Tips

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Study Coordinator Career Advancement Tips 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 [email protected] TOPICS: - Career Options - Educational Opportunities - Certifications - Training Opportunities - JHU Career Progression CAREERS IN CLINICAL RESEARCH Government Pharma Study Coordinator 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 do 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 classes on top of your current schedule JOHNS HOPKINS SCHOOL OF PUBLIC HEALTH Master of Public Health and Doctor of Public Health (MPH/DrPH) Master of Public Health and Master of Master of Health Business Administration (MPH/MBA) Administration (MHA) Master of Public Health and Master of Social Master of Health Science Work (MPH/MSW) (MHS) Master of Public Health and Master of Science in Nursing (MPH/MSN) Master of Public Health (MPH) Master of Public Health and Juris Doctor Master of Science in Public (MPH/JD) Health (MSPH) Master of Arts and Master of Science in Public Master of Science (ScM) Health (MA/MSPH) Bachelor of Arts and Master of Health Science Master in Public Policy (MPP) or Bachelor of Arts and Master of Science in Public Health (BA/MHS) Master of Science in Public Health and Registered Dietitian (MSPH/RD) Doctor of Philosophy (PhD) Doctor of Medicine and Doctor of Philosophy Doctor of Science (ScD) (MD/PhD) Concurrent Master's Programs for Doctoral Doctor of Public Health (DrPH) Students CLINICAL DEGREES - Nursing, Physician Assistant, Medical School - Provide greater responsibility - Great opportunity for those who know that they what to stay within a job that includes participant interaction JHU TUITION REMISSION http://benefits.jhu.edu/tuition/remission.cfm - You are eligible for tuition remission once you have completed 120 days of full-time employment as long as you are JHU faculty, staff or a retiree. - Visiting faculty and staff, residents, interns and post-doctoral fellows are not eligible for tuition remission JHU TUITION REMISSION CONT. - Part-time credit and non-credit courses offered through the continuing education unit of one of JHU’s academic divisions are covered under this plan. - Outside courses, conferences, and seminars may also be covered if required for the employee to maintain a job-required professional certificate or license regulated by the State Licensing Board. JHU TUITION REMISSION CONT. - There is a $5,250 annual family limit on tuition remission for faculty, staff, retirees - You are responsible for any spending that exceeds the limits, and for tuition costs for courses not completed (i.e., withdrawn or dropped). - Faculty, staff, and retirees are eligible for 100% remission for credit courses, and 25% remission for private credit instruction at Peabody. CLINICAL RESEARCH SPECIFIC DEGREES - Degree that are specific to clinical research - Becoming more popular - Online classes CLINICAL RESEARCH SPECIFIC DEGREES - Drexel University: Link to Degree Program Information Master of Science in Clinical Research Organization and Management Master of Science in Clinical Research for Health Professionals Certificate of Study in Clinical Research Quantitative Principles for Clinical Research Certificate CLINICAL RESEARCH SPECIFIC DEGREES - Pitt CTSA-CTSI - http://www.icre.pitt.edu/degrees/degrees.html - UC San Diego - http://clre.ucsd.edu/ - UCSF Pharmacy School - http://pharmacy.ucsf.edu/mscr/ - GW - http://www.gwumc.edu/healthsci/academics/crabout.cfm CERTIFICATION: - Becoming more standard in job requirements - A lot of programs out there - SoCRA vs ACRP SOCRA: WWW.SOCRA.ORG/ - Society of Clinical Research Associates - 13,800+ Members - 9000+ Certified Clinical Research Professionals (CCRP) - In 2012, they had 40+ educational programs, and 81 testing sites SOCRA: applicant must be a current member of SoCRA ELIGIBILITY CATEGORIES – Category 1: Candidates having completed a minimum of 2 years of full time employment (or 3500 hours of part-time employment) during the past five years as a clinical research professional. Category 2: Candidates holding a degree in “Clinical Research” from an Associate, Undergraduate or Graduate Degree Program AND having completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional. Category 3: Candidates holding an Undergraduate or Graduate Certificate in “Clinical Research” with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND holding an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND having completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional. SOCRA: Identify and differentiate the foundations and The Nuremberg Code principles of clinical research ethics. 5% The Belmont Report Demonstrate knowledge of laws, regulations, The Declaration of Helsinki guidance, and standard operating procedures and their application to regulated clinical 21 U.S. Code of Federal Regulations – research. Parts 11, 50, 56, 312, 812 20% 45 U.S. Code of Federal Regulations - Part Distinguish and define the responsibilities of 46 sponsors, monitors, and investigators according to the principles of the International FDA Information Sheets for Clinical Conference of Harmonization, Good Clinical Investigators Practice (ICH/GCP) and the Code of Federal Regulations (CFR). ICH GCP Guideline for Good Clinical 15% Practice (E6), and Identify and apply the regulations and guidance as ICH Clinical Safety Data Management: they relate to informed consent, IRB/IECs, and Definitions and Standards for financial disclosure. Expedited Reporting 15% Identify the principles of study design, study closure, and record retention. 15% Demonstrate knowledge and application of safety reporting requirements. 5% Demonstrate the ability to utilize critical thinking skills in practical applications. 25% SOCRA: Q1. Informed consent documents must include the following: a. A statement that the study involves research. b. A statement of the possible risks. c. A discussion of possible alternative treatments. d. All of the above. Q2. Responsibility for the participant's safety lies with: a. The sponsor b. The investigator c. The IRB Q3. Which of the following would require the breaking of a randomization code in a blinded study? a. The participant withdraws from the study before its conclusion. b. Participants in only one of the investigating sites show any definite response to treatment. c. A participant experiences a serious adverse experience, the etiology of which cannot be explained. d. None of the above. Q4. The responsibility for ensuring that the investigator Understands a clinical trial lies with: a. The FDA b. The IRB c. The Sponsor d. None of the above SOCRA: - Costs: - Membership= $75 per year (3 year cycle) - Certification Fee = $195 - Recertification Fee = $100 SOCRA: - Upcoming Exam Times: - Sept 18, 2012 – Sinai Hospital 9am – 1pm registration deadline August 8, 2012 - Nov 16, 2012 – Radisson In conjunction with the SoCRA/FDA Regulation Workshop 8 am – 12 pm registration deadline: Oct 5, 2012 ACRP: WWW.ACRPNET.ORG/ - Society of Clinical Research Associates - 18,000 Global Members - 3 different certification - CRA, CRC, PI - Only offers testing twice a year, but testing is offered at Prometric Testing Sites ACRP: - CRA –Certified Clinical Research Associate (CCRA) . A CRA is a professional who, regardless of job title, monitors (in- house or in the field) the administration and progress of a clinical trial on behalf of a sponsor. ACRP: - CRC –Certified Clinical Research Coordinator (CCRC) .A CRC is a professional who, regardless of job title, works at a clinical research site under the immediate direction of a principal investigator, whose research activities are conducted under Good Clinical Practice (GCP) Guidelines. ACRP: - PI –Certified Principal Investigator(CPI) . a physician (MD or equivalent degree) who serves as the primary, sub-, or co- investigator; or monitors, supervises, or designs clinical trials; and accepts responsibility for the safe and ethical conduct of a clinical trial.
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