Clinical Trial Manager

Kim M. Doeden

**** ********, ******, ** *****

E: *********@*****.*** ( M: 612-***-****

linkedin.com/pub/kim-doeden/10/748/b55

EPIDEMIOLOGY, RESEARCH, AND REGULATORY AFFAIRS

Experienced Clinical Trial Manager with over ten years managing all aspects

of clinical trials in a highly regulated environment.

PROFESSIONAL EXPERIENCE

Memorial Blood Centers (MBC) ( St. Paul, MN ( 02/2007 - 07/2014

MBC is a Minnesota-based, independent nonprofit organization that has been

providing blood products, laboratory services, and research/clinical trial

expertise for 60 years.

Clinical Trial Manager/Regulatory Affairs Specialist

. Managed operational activities of all clinical trials, including

medical device and pharmaceutical

. Work with the Principal Investigator and Sponsor to develop study

protocols, budgets and contracts

. Prepared FDA submissions (INDs, IDEs, BLAs, 510Ks, Annual Reports

etc.) and act as principal point of contact with FDA on licensure

. Oversaw Research Assistant

. Created all study materials (e.g. consent forms, CRFs, tracking logs)

and progress reports

. Ensured compliance with 21 FDA CFR, ICH, cGMP and GCP guidelines

. Prepared and managed IRB submissions and FWA applications

. Initiated/trained and monitored field sites for protocol and

regulatory compliance

. Created and maintained study databases

. Developed and reviewed all research-related SOPs and training courses,

including Human Subjects Protection

. Hosted and responded to Sponsor, FDA, AABB, CLIA, EU, and other

regulatory agency audits for both clinical trials and blood center

operations

. Researched, prepared and coordinated submissions for out-of-state

Clinical Laboratory Licensure

. Coordinated procurement of blood components and samples for research,

including recruitment, logistics between departments, pricing, donor

payment, and invoicing

. Project lead for multiple projects including Emergency Preparedness

Planning, Pandemic Flu Preparedness and IATA Compliance/Shipping

Biospecimens

. Collaborated with State and local experts on Disaster Planning and

Awareness

RTI International ( Washington, D.C. ( 01/2004 - 02/2007

RTI International is one of the world's leading research institutes with a

staff of more than 3,700. RTI provides research and technical services to

governments and businesses in more than 75 countries in many areas

including health and pharmaceuticals, surveys and statistics, and

laboratory testing.

Epidemiologist

. Managed large, multi-site epidemiologic studies concerning

chronic and infectious disease epidemiology both

internationally and domestically

. Responsible for monitoring data collection activities,

biospecimen shipping and handling, and quality control

procedures.

. Implemented quality control of collected data through the

processing, editing, and querying of data collection

instruments prior to data entry

. Maintained database system for several studies

. Prepared materials for IRB submission, develop codebooks,

and prepare reports for clients

. Monitored field sites for protocol adherence and regulatory

compliance

The Services Group, Inc. ( Arlington, VA ( 01/2000 - 08/2003

The Services Group (TSG) was an economic development firm (currently AECOM

Tech Corp as of 2008),

Assistant Project Administrator

. Acted as principal point of contact for overseas consultant

on USAID-funded projects, which included ensuring

compliance with USAID regulations, arranging travel,

obtaining visas and country clearances, and analyzing

expense reports.

VOLUNTEER POSITIONS/INTERNSHIPS

AABB ( Bethesda, MD ( 09/2012 - Present

AABB has been a leader in the development of standards for blood banks and

transfusion services since 1957.

AABB Assessor (Volunteer)

. Evaluate the Quality and Operational systems of various blood centers

to determine whether the service they provide is appropriate and in

control according to AABB Standards

Arlington County Dept of Health ( Arlington, VA ( 2003

Environmental Health Program

Intern

. Performed field work for Environmental Health Bureau's

efforts to monitor West Nile Virus in Arlington County,

including catch basin treatments, park inspections,

disseminating surveillance information to local residents,

setting and retrieving mosquito traps, and other various

tasks as assigned

EDUCATION

Master of Public Health

Concentration in Epidemiology

Medical College of Virginia, VCU, Richmond, VA, 2003

Bachelor of Science in Health Promotion and Exercise Physiology

George Mason University, Fairfax, VA, 2001

TECHNICAL SKILLS

Microsoft Office Suite: Microsoft Word ( Excel ( Access ( Project (

PowerPoint

SafeTrace ( MasterControl ( Hemasphere ( Internet Research

TRAINING AND WORKSHOPS

. AABB Annual Meeting & CTTXPO, Denver, CO, 2013

. AABB Assessor Continuing Education, Denver, CO, 2013

. OHRP Workshop, Developing Your Human Research Protections Program:

Regulatory Compliance and Additional Considerations, Minneapolis, MN,

2012

. NIH Human Subjects Protection, Online Course, 2012

. AABB Assessor Training, San Diego, CA, 2011

. AABB Annual Meeting & CTTXPO, San Diego, CA, 2011

. Emerging Infections Conference, University of MN, 2011

. SafTPak IATA Training for Shipment of Dangerous Goods, Online Course,

2011

. AABB Annual Meeting & CTTXPO, Baltimore, MD, 2010

. Project Management Training, Memorial Blood Centers, St. Paul, MN, 2010

. OHRP Research Community Forum, "Regulatory Responsibility and Innovative

Research- An Opportunity for Partnership", Chicago, IL, 2010

. CitiProgram Human Subjects' Training, Online Course, 2010

. FDA Regulation and Licensure of Whole Blood and Blood Components,

Including Source Plasma; Public Workshop, Rockville, MD, 2009

. Preparedness Practicum, Hennepin County Medical Center, Minneapolis, MN,

2009

. MLS Metro Regional Lab Conference (Emergency Preparedness), St. Paul,

MN, 2008

CONTRIBUTIONS AND ACKOWLEDGMENTS

Donor hemoglobin and iron replacement study. J. Gorlin, K. Doeden, D.

Elsmore, A. Hove, L. Katz, K. Kirbach. AABB Poster 2013

Similar Donors - Similar Blood? M. Tarasev, K. Alfano, S. Chakraborty, L.

Light, K. Doeden, J. Gorlin. Transfusion 2013 Volume 54, Issue 3pt2,

March 2014, Pages: 933-941

Role of Inter-Donor Variability on the Autolysis and Fragility of RBC Units

and Segments. M. Tarasev, S. Chakraborty, K. Alfano, K. Doeden, J. Gorlin.

AABB Presentation 2012. Transfusion, Volume 52, Supp.1, p. 100A.

Obstetric Hemorrhage: Development of a comprehensive educational

curriculum for OB-Gyn MDs, RNs and incorporating laboratory staff. J.

Gorlin, J. Francis, K. Doeden, N. VAnBuren. AABB Poster 2012

Field trial validation of a microfluidic device which simultaneously

determines and individual's ABL and Rh blood groups. D. Wierzbicki, J.

Gorlin, K. Doeden, L. Katz, P. Sullivan, J.W. Smith, E. Moore. AABB Poster

2010

Blood spots as an alternative to whole blood collection and the effect of a

small monetary incentive to increase participation in genetic association

studies, Bhatti P et al. BMC Medical Research Methodology 2009, 9:76

Interobserver reliability and accuracy of cranial ultrasound interpretation

in premature infants. Hintz SR et al. J Pediatr. 2007 June; 150(6): 592-

596.e5

MHCS-II:Chronic hepatitis B and other correlates of spontaneous clearance

of hepatitis C virus among HIV-infected people with hemophilia. Melendez-

Morales L et al.

EPIDEMIOLOGY AND SOCIAL. AIDS. 21(12):1631-1636, July 31, 2007

Reconstruction of the Hepatitis C Virus Epidemic in the US Hemophilia

Population, 1940-1990. Goedert JJ et al. Am. J. Epidemiol. (2007) 165

(12): 1443-1453

Correlates of spontaneous clearance of hepatitis C virus among people with

hemophilia. Blood. Mingdong Z et al. 2006 February 1; 107(3): 892-897

Master's Thesis: Association Between Source of Prenatal Care and Low Birth

Weight: Public Health Department vs. Private Physician's Office, K. Doeden.

Virginia Commonwealth University, 2003

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