Management Manager

Curriculum Vitae for

Megan M. Dunn, PhD

Summary:

- 7 yrs of experience in clinical research: Clinical Research Manager;

CRA/CRC; SOP writing; protocol and CRF writing; data management and

analysis (Rave, Oracle, InForm, SPSS); study start-up, management, and

close-out; journal article and presentation writing; regulatory and

IRB document prep and management; in-house monitoring/QA; enrollment

monitoring

- MS in Health Science - Clinical Research Administration; PhD in Health

Science- International Research

- Strong academic and working knowledge of ICH GCP and FDA clinical

research guidelines

Personal Information

Home Address 1650 White Oak Ln #1

Schaumburg, IL 60195

Phone 312-***-****

E-mail Address *****.****@**.*******.***

Education and Certification

Trident University International PhD in Health Sciences

August 2012 International Researcher/Educator

Summa Cum Laude

Touro University Master of Science in Health Science

September 2008 Clinical Research Administration

Summa Cum Laude

CITI Collaborative Institutional Training GCP / Clinical Coordinators

2011 Curriculum

National Cancer Institute Human Participant Protection

2006/2007/2008/2009/2010 Education for Research Teams

Rockford College BA Psychology/ BA Studio Art

May 2005 Phi Beta Kappa

Psi Chi

Summa Cum Laude

British American College of London Semester Abroad

Fall, 2004 London, England

Employment History

Blue Chip Marketing Clinical Enrollment Specialist

May, 2012- Present

. Responsible for the oversight of enrollment for 25 clinical research

sites

. Responsible for subject retention education and monitoring for 88

sites

. Regional travel for on-site enrollment education and planning

. Bi-weekly contact with sites for enrollment monitoring

. Liaise among the research site, marketing company, sponsor, and CRO

. Motivate and encourage study staff to fulfill their site's enrollment

goals for a weight loss trial resulting in over 9,000 subjects

enrolled within 4 months

. Part of team responsible for condensing a clinical trial enrollment

period by 66%

Alexian Brothers Behavioral Health Hospital Research Manager

June, 2011- May, 2012

. Responsible for managing the Alexian Brothers Center for Psychiatric

Research providing direct clinical and administrative supervision

. Day-to-day oversight of ten full-time employees and 12+ psychiatric

research trials

. SOP development and maintenance

. Quality control and assurance through monthly internal auditing

. Ensure all regulatory and professional standards are maintained

. Prepare and monitor departmental budget

. Responsible for ongoing business development through managing patient

recruitment and new study start-up

Adventist Midwest Health CRC/CRA

November, 2010- May, 2011

. Responsible for patient recruitment and enrollment in clinical trials;

managed day-to-day activity of clinical trials working closely with

the investigators and nurses on research protocols

. Implemented and managed a research department specific pharmacy

. Wrote and implemented research department SOPs

Orchard Healthcare Research Inc/ CRC/CRA

Peryam and Kroll Healthcare Research October, 2008- November, 2010

. Responsible for patient recruitment and enrollment in clinical trials;

managed day-to-day activity of clinical trials working closely with

the investigators and nurses on research protocols

. Conduct internal audits on satellite sites for quality-assurance and

protocol compliance. This includes monitoring six sites in the Chicago

area and developing/implementing actions plans to address findings

. Responsible for data management of approximately 200 study patients

active and in follow-up. This included working with IVRS and EDC

systems such as Medidata, Inform, and Rave

. Responsible for study initiation and closure activities

. Responsible for drug accountability, drug storage, drug dispensing and

drug administration for six sites

. AEs and SAEs collection and reporting

. Responsible for IRB submission, annual reviews, and maintenance of

regulatory documents including FDA form 1572

. Participates in Investigator Meetings with the Principal Investigator

for new studies

Rockford College Assistant Professor- Neuroscience

Spring 2008, 2009, Fall 2009

. Developed curriculum for a four credit hour, undergraduate course for

the Psychology Department, including text book selection, supplemental

reading selection, exam writing, and grading criteria

. Instructed the course

Illinois Bone and Joint Institute Research Coordinator (CRC)

November, 2005- October, 2008

. Protocol/consent form/manuscript preparation and writing for all

investigator initiated studies

. Study budget preparation for all investigator initiated studies

. Final data analysis using SPSS

. Lecture preparation and writing for scientific meetings and

presentations both domestic and international

. Responsible for patient recruitment and enrollment in clinical trials;

managed day-to-day activity of clinical trials working closely with

the investigators and nurses on research protocols

. Responsible for all IRB submissions and annual reviews

Adapt of Illinois Mental Health Professional

June, 2005- October, 2005

. Worked in long-term residential facility for adults with mental

illness

. Wrote individualized treatment plans for all assigned patients

. Liaison among facility management, Adapt of Illinois, family, patient,

physicians and insurance companies

. Responsible for conduct and documentation of daily individualized

therapy

. Responsible for daily conduct of small group therapy

Clinical Trial Experience/Therapeutic Specificity

. Phase II-IV oncology trials including the following indications:

brain, breast, endocrine, genitourinary, head and neck, leukemia,

lung, melanoma, myeloma and prostate

. Investigator initiated trials for the following orthopedic

indications: scoliosis (pediatric and adult), spinal imaging, Down

syndrome related cervical instability, spinal balance, and vertebral

fractures

. Device trails for the following orthopedic indications: vertebral

collapse, disc replacement, infantile congenital scoliosis, and bone

regeneration

. Phase I-IV psychiatric trials including the following indications:

schizophrenia,

major depressive disorder, and autism

. Phase III weight loss trial

Publications

1. Knott P, Mardjetko S, Nance D, Dunn M. Electromagnetic Topographical

Technique of Curve Evaluation for Adolescent Idiopathic Scoliosis.

Spine. 2006; 31(24): E911-E915.

2. Knott P, Mardjetko S, Techy F, Dunn M, Pullara T, Kennedy J, McCall T.

The Use of T1 Tilt Angle in Predicting Overall Sagittal Balance. The

Spine Journal. 2008; 8(5): 136S.

3. Knott P, Mardjetko M, Kim R, Cotter T, Dunn M, Patel S, Spencer M,

Wilson A, Tager D. A Comparison of Magnetic and Radiographic Imaging

Artifact After Using Three Types of Metal Rods: Stainless Steel,

Titanium, and Vitallium. The Spine Journal. 2010.

Lectures for Scientific Meetings

1. Knott PT, Mardjetko SM, Nance DK, Dunn MM. Experience with an

Electromagnetic Topographical Technique of surface Evaluation for

Adolescent Idiopathic Scoliosis. American Academy of Pediatrics

National Conference and Exhibition, Atlanta, Georgia. October 7-8,

2006.

2. Knott, P, Mardjetko, SM, Dunn, M. The Use of Surface Topography in the

Surveillance of Adolescent Idiopathic Scoliosis: The Influence of

Patient BMI on the Reliability of Curve Measurement. SOSORT 5th

International Conference on Conservative Management of Spinal

Deformities. Athens, Greece. April, 2008.

3. Knott, P, Mardjetko, SM, Dunn, M. Evaluating the Influence of Patient

Positioning on the Accuracy of Ortelius 800 Meaurements for Scoliosis.

SOSORT 5th International Conference on Conservative Management of

Spinal Deformities. Athens, Greece. April, 2008.

4. Knott, P, Mardjetko, SM, Dunn, M, Techy, F. Sagittal T1 Tilt Angle and

it's Correlation with Other Predictors of Spinal Balance. IMAST. Hong

Kong, China. July, 2008.

5. Knott, P, Mardjetko, SM, Dunn, M. Evaluating the Influence of Patient

Positioning on the Accuracy of Scoliosis Measurements Using Surface

Topography. IMAST. Hong, Kong, China. July, 2008.

6. Dunn, M. Key Points for the Proper Conduct of Clinical Research with

Inpatients. Alexian Brothers Behavioral Health Hospital. Hoffman

Estates, IL. January, 2012.

Research Group Associations

1. Medtronic Sofamor Danek Spinal Deformity Study Group: Adult Deformity

Outcomes Study, Prospective Pediatric Scoliosis Study, The Effect of

Surgery on Sagittal Spino-pelvic Measures of Balance in

Spondylolisthesis

2. Scoliosis Research Society: Morbidity and Mortality Database, Global

Outreach Program

3. Axial Biotech: Linkage Analysis and Gene Mapping of Several Mendelian

Malformation Syndromes

4. San Diego Center for Spinal Disorders: Dual Rod Instrumentation with

Limited Fusion for the Treatment of Progressive Early Onset Scoliosis.

5. Complex Spinal Deformity Study Group: Adult and Pediatric Spinal

Deformity and Trauma

6. Eastern Cooperative Oncology Group: Phase II, III, and IV oncology

trials

7. Cancer and Leukemia Group B: Phase II, III, and IV oncology trials

Investigator Initiated Studies

1. Vertical Expandable Prosthetic Titanium Rib (VEPTR): Lutheran General

Hospital, Hope Children's Hospital, and Christ Medical Center

2. An Orthopedic Survey of a Population of Adults with Down Syndrome:

Lutheran General Hospital.

3. The Use of The Ortelius 800 by Orthoscan Technologies to Monitor and

Diagnose Adolescent Idiopathic Scoliosis: Rosalind Franklin University

of Medicine and Science.

4. Spinal Fusion Using Bone Morphogenetic Protein-2: Lutheran General

Hospital.

5. Postoperative Evaluation of Serial Venous Duplex Scans and the Effect

on Detecting Deep Vein Thrombosis: Lutheran General Hospital, and

Illinois Bone and Joint Institute.

6. Comparison of Metallic Spine Implant Systems and Their Effect on MRI

and CT Artifacts: Stryker Spine, Illinois Bone and Joint Institute,

and 3T Imaging.

7. Sagittal T1 Tilt as it Relates to Overall Spinal Balance: Rosalind

Franklin

University of Medicine and Science, Illinois Bone and Joint Institute

8. Patient Positioning and the Effectiveness of the Orthoscan, BMI and

the

Effectiveness of the Orthoscan: Rosalind Franklin University of

Medicine and

Science, Illinois Bone and Joint Institute

Attendance at Educational/Scientific Meetings

1. Medtronic Sofamor Danek, Prestige LP Artificial Cervical Disc System,

Investigator Meeting. Memphis, TN, 2006.

2. ISMIE, Office Risk Management Practices. Skokie, IL. April 4, 2006.

3. ISMIE, Treating Patients with CARE. Morton Grove, IL. May 5, 2006.

4. 8th Annual Chicago Trauma Symposium. Chicago, IL. July 27-30, 2006.

5. The Aging Spine: Challenges and Techniques. Lake Geneva, WI. August 11-

12, 2006.

6. Illinois Bone and Joint Institute Worker's Compensation Seminars,

Rosemont, IL, January 2007, May 2007, October 2007, February 2008.

7. Millennium, Chronic Lymphocytic Leukemia, Investigator Meeting. Miami,

FL, 2008.

8. Astra Zeneca, The Zest Trial, International Results Meeting. Dallas,

TX, 2009.

9. Wyeth, 3004-3005 Narantinib Trials, Investigator Meeting. Boston, MA,

2009.

10. Celgene, Connect: The Multiple Myeloma Registry, Investigator Meeting.

Altanta, GA. 2009

11. Eisai, PALO 08-13 Trial, Investigator Meeting, Jersey City, NJ, 2009.

12. Celgene, CLL Registry, Investigator Meeting. San Diego, CA. 2010.

13. ImClone, REACH, IMCL CP12-0919, Investigator Meeting. Chicago, IL.

2010.

14. Forest Research Institue, LVM-MD-10 Recruitment Strategies. Boston,

MA. 2011.

15. Astra Zeneca, AZD6765 The Infusion Study, Investigator Meeting. San

Diego, CA. 2012

16. Forest Research Institute, VLZ-MD-02, Investigator Meeting. Jersey

City, NJ. 2012.

17. Orexigen Therapeutics, NB-CVOT, Investigator Meetings 1 and 2, Las

Vegas, NV, 2012.

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