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

Study Coordinator

Clinical Research

Research Management

Pharma

Government

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 Health

Administration (MHA) Master of Health Science

(MHS) Master of Public Health (MPH) Master of Science in Public

Health (MSPH) Master of Science (ScM) Master in Public Policy (MPP) Doctor of Philosophy (PhD) Doctor of Science (ScD) Doctor of Public Health (DrPH)

Master of Public Health and Doctor of Public Health (MPH/DrPH)

Master of Public Health and Master of Business Administration (MPH/MBA)

Master of Public Health and Master of Social Work (MPH/MSW)

Master of Public Health and Master of Science in Nursing (MPH/MSN)

Master of Public Health and Juris Doctor (MPH/JD)

Master of Arts and Master of Science in Public Health (MA/MSPH)

Bachelor of Arts and Master of Health Science 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 Medicine and Doctor of Philosophy (MD/PhD)

Concurrent Master's Programs for Doctoral 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.

Identify and differentiate the foundations and

principles of clinical research ethics. 5%

Demonstrate knowledge of laws, regulations, guidance, and standard operating procedures and their application to regulated clinical research. 20%

Distinguish and define the responsibilities of sponsors, monitors, and investigators according to the principles of the International Conference of Harmonization, Good Clinical Practice (ICH/GCP) and the Code of Federal Regulations (CFR). 15%

Identify and apply the regulations and guidance as they relate to informed consent, IRB/IECs, and financial disclosure. 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%

The Nuremberg Code The Belmont Report The Declaration of Helsinki 21 U.S. Code of Federal Regulations –

Parts 11, 50, 56, 312, 812 45 U.S. Code of Federal Regulations - Part

46 FDA Information Sheets for Clinical

Investigators ICH GCP Guideline for Good Clinical

Practice (E6), and ICH Clinical Safety Data Management:

Definitions and Standards for Expedited Reporting

SOCRA:

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. In 2001, the first PI exam was offered. Since

then, almost 900 PIs across the globe have learned their CPI® designation.

ACRP

Discounted fees if applicant is a current member of ACRP

ELIGIBILITY CATEGORIES – Option 1 Associates or Bachelor’s degree (or higher) OR Registered Nurse (RN) 3,000 hours performing essential duties Detailed CV/resume AND Job Description Option 2 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:

1. Investigational Product Management 2. Protocol 3. Safety 4. Trial Management 5. 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, 2 to 3:30 p.m. – Tilghman Auditorium Session 2: Tuesday, Oct. 9, 2 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 do 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 Role Level Range Data Assistant ACRO 1 CA Research Program Assistant ACRO 2 CB Research Program Assistant II ACRO 2 CC Research Program Coordinator ACRO 3 CD Research Program Supervisor ACRO 3 CE Sr. Research Program Coordinator ACRP 3 MB Sr. Research Program Supervisor ACRP 3 MC Sr. Research Program Coordinator II ACRP 4 MC Research Manager ACRP 4 MD Sr. Research Manager ACRP 4 ME Research Associate faculty

http://hrnt.jhu.edu/pay/salary_ranges.cfm