Research Administration

EDUCATION

EMMANUEL COLLEGE, Boston, MA

Graduate Studies + Nursing

Master of Science in Management: Research Administration (Online)

Expected Graduation: December 2015

MICHIGAN STATE UNIVERSITY, East Lansing, MI

College of Arts and Letters

Bachelor of Arts

1992 - 1996

PROFESSIONAL EXPERIENCE

LEAD IRB ANALYST

VA Portland Health Care System

January 2015 - Present

GRANTS & IRB ANALYST

VA Portland Health Care System

March 2007 - December 2014

Portland, OR

. Lead IRB (Institutional Review Board) analyst duties include

supervising four IRB analysts in the conduct of their duties and

responsibilities.

. Primary function as lead is to evaluate the Human Subjects Protection

Program for effectiveness and to design training programs and

organizational strategies for identifying opportunities to improve

customer service and process quality within the area of human subjects

research and associated functions.

. Represents IRB analysts in dealings with oversight agencies and in

securing necessary tools and information from both internal and

external entities to conduct required job functions.

. Certified IRB Professional (CIP) certification earned March 2012.

. Pre-award grant management. Recipient and tracking coordinator for

Notice of Grant Awards (NOGAs), VA Career Development, VA Career

Scientist, and VA Merit Review funding notices.

. Compile and submit annual VA Research and Development Information

System (RDIS) II report. Report summarizes end-of-fiscal-year

information for all local VA researchers. Includes non-VA administered

funds.

. Track funding for all grants including both VA and non-VA funding

sources.

. Routinely utilize ePROMISe (Enterprise Project Management Information

System) to track VA research projects.

. Track annual Investigator Data Sheet receipt and accuracy.

. Coordinate receipt of annual Financial Conflict of Interest

disclosures and assist in ensuring management plans are initiated when

required.

. Trained in the protection of human subjects in research. CITI

(Collaborative Institutional Training Initiative) requirement most

recently completed March 2014.

. Familiar with and routinely apply the ethical principals described in

the Belmont Report, Declaration of Helsinki, and Good Clinical

Practice (GCP) guidelines.

. Routinely comply with the Common Rule; the U.S. Department of Health

and Human Services Code of Federal Regulations 45 CFR 46 Subparts A

through D and of the Food and Drug Administration (FDA) regulations 21

CFR 50.

. Experienced with preparation and for audits conducted by the Office of

Research Oversight (ORO) and Federal Drug Administration (FDA).

. Assisted in preparation for successful accreditation review by the

Association for the Accreditation of Human Research Protection

Programs, Inc. (AAHRPP).

. Review Quality Assurance or Quality Improvements (QA/QI) proposals to

ensure they are not research as determined by guidelines in the VHA

Handbook 1058.05.

. Provide individual and group regulatory, local policy, and GCP

training to IRB members and study team personnel both at the Portland

VA Medical Center and at Oregon Health and Science University.

. Review VA Scope of Work forms for accuracy and relevance to specific

human research studies.

. Maintain standards set forth by the Portland VA IRB Policies and

Procedures, ORO and AAHRPP in practices designed to protect human

subjects in research.

. Assist coordination of local studies under VA Central IRB oversight.

. Coordinate PVAMC IRB and Affiliate OHSU/VA IRB.

. Use MIRB software to manage all materials submitted for IRB review and

all correspondence between investigators and the IRB.

. Use eIRB software in conjunction with Oregon Health & Science

University (OHSU) research staff to facilitate the combined IRB

overseeing studies at both institutions.

. Assist in implementation of IRB7 as new research tracking software to

be used at both the Portland VA and OHSU.

. Process and audit IRB submissions from investigators that include, but

are not limited to, initial review submissions, continuing review

submissions, amendments, research personnel change requests, informed

consent revisions, and safety reports and unanticipated problem

reports.

. Coordinate IRB meetings. Duties include, but are not limited to,

assigning appropriate IRB reviewers for each submission for review,

determining submission from the investigator is complete,

disseminating materials to IRB reviewers for review with ample time to

complete the review prior to the meeting, ensuring that all study

related materials pertinent to the review are available to the IRB

members, and ensuring investigators are provided an opportunity to

discuss their study with the IRB members directly.

. Record accurate notes at each IRB meeting and transcribe them into

complete minutes documentation for record.

. Distribute IRB stipulations to investigators, ensure a response from

investigator is received and forward the response to IRB reviewers.

Maintain timely correspondence with investigators regarding their

submission and its progress through the IRB review process.

. Conduct thorough pre-review audits of investigator submissions for

completeness, accuracy, and errors prior to IRB review.

DIRECTOR OF RESEARCH; CLINICAL RESEARCH COORDINATOR

Westover Heights Clinic

Portland, OR

January 2003 - August 2006; Clinical Research Coordinator

August 2006 - March 2007; Director of Research

. Responsible for coordinating an average of ten research study protocols

simultaneously while working within contracted budgets and constant

deadlines. Successfully prioritize between deadlines, sponsors,

Institutional Review Boards, and participant needs.

. Primary contact person for study sponsors, Institutional Review Boards,

principal investigators, and sub-investigators.

. Met or exceeded recruitment goals in over 95% percent of studies

coordinated. Responsible for creating advertising plans and recruitment

materials.

. Maintained study related documents in an organized manner conducive to

monitor and audit review.

. Certified as a Clinical Research Coordinator through the Association of

Research Professionals (ACRP) in October 2004.

. Performed HerpeSelect HSV-1 and HSV-2 ELISA assays weekly.

. Supervised research department staff.

. Responsible for financial success of research department.

HEALTH CENTER MANAGER

Planned Parenthood of the Rocky Mountains

Cortez, CO

January 2001 - December 2001

. Responsible for all functions of rural health center including budget,

medical billing, hiring and managing staff, and cashiering.

. Performed in-office labs including urinalysis, HIV tests, pregnancy

tests, and blood pressures.

. Worked extensively with local health department and public school system

to promote health care in small, rural community.

ASSOCIATE MANAGER OF THE FAMILY PLANNING CLINIC; MEDICAL ASSISTANT;

COUNSELOR

Planned Parenthood of Mid-Michigan

Ann Arbor, MI

May 1996 - May 2001

. Responsible for staff including medical assistants, nurse practitioners,

and counselors. Coordinated volunteer staff, staff schedule, and

inventory management.

. Busy clinic demanded prioritizing patient needs with employee needs on a

daily basis.

. Triaged medical questions from patients, counseled regarding

contraceptive methods, sexually transmitted diseases, and pregnancy

options. Performed HIV tests, assisted in surgical procedures, and

processed lab specimens for shipment.

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