Manager Management
Resume:
Susan L. Wirth MSN / HCM CCRC
Westlake, OH 44145
************@*****.***
www.linkedin.com/pub/susan-wirth/78/189/736
CAREER SUMMARY
Accomplished Research Management Professional with extensive experience
leading research operations, projects, and establishing new and existing
initiatives and research programs. Unique expertise in developing and
implementing opportunities and solutions, negotiating and managing research
contracts, directing complex research protocols from concept to fully
operational status, while working in unison with all levels internal and
external to the organization. Possesses a unique combination of clinical
and analytical skills honed through years of extensive experience in
research protocol review, research financial management, laboratory /
biorepository management, research compliance, and federal compliance
regulations. Specific expertise in the following:
Innovative / Collaborative Grant Development, Pre- and Post-Award
Leadership
Research Service Line Creation / External Institutional Relations
Execution
Financial Budgeting and Forecasting Contract Management / Consulting
Agreements
Contract / MTA Negotiations Regulatory / Compliance / Quality
Assurance
Training / Mentoring Pharmaceutical and Medical Device Trials
Employee Engagement MS Office, GAMS, myCert, Lawson, CROP,
FDA Regulations and Guidelines IRB, Webkit, KRONOS
PROFESSIONAL EXPERIENCE
The Cleveland Clinic, Cleveland, OH 1982 - 8/2013
World class, multispecialty, academic medical center ranked in the top four
hospitals in the nation. System consists of 10 hospitals and 17 family
health and ambulatory surgery centers.
Clinical Research Program Manager
Genomic Medicine Institute (GMI) 2009 - 8/2013
Handled comprehensive management of multi-disciplinary research team and
execution and coordination of multi-center academic trials, inclusive of
pre- and post- award activities, regulatory compliance, and biorepository
service line processes.
. Set forth and developed a Genomic Medicine Biorepository Core service
line, establishing an interdisciplinary team aimed at processing human
samples for downstream high throughput genomic sequencing, resulting in
an $85,000 new revenue stream in 2013.
. Developed an interdisciplinary organizational structure to manage
clinical research personnel, data systems (Labmatrix), and a GMI
biorepository (10,000 patient enrollments).
. Established pricing for biorepository sample processing and storage
services, including RNA, DNA, cell lines, and protein creation, into an
integrated billing system (CORES) for reimbursement.
. Initiated an external bioinformatics consulting agreement to optimize
database support services within Lerner Research Institute (LRI) and GMI.
. Developed and maintained a comprehensive clinical research compliance
program within GMI, addressing IRB audit findings. Instrumental in
removing IRB research study holds. Developed a compliance binder tool for
LRI human subject research compliance.
. Increased Gallup engagement scores from 75th percentile in 2011 to 87th
percentile in 2012 - Highest in GMI. Developed Gallup SMART action plans
targeting team-building, communication, and recognition ($250 tier three
caregiver award). Planned and executed GM's off-site team-building
retreats in 2011 and 2012 for 80 people.
The Cleveland Clinic, Clinical Research Program Manager (continued)
. Developed a collaborative and team focused clinical research program
aimed at engaging and empowering employees. Mentored two employees in
Lerner Research Institute Assistant Administrator Program. Ensured
appropriate staffing and skill level of departmental personnel through
guided individual development plans.
. Participated in launch of a new institute within CCF: The Center for
Personalized Medicine (CPH). As an intern, participated in development of
marketing tools, media relations, educational venues, budgeting,
governmental relations, and introduction of a clinical decision support
tool (MyFamily).
Research Manager, Department of Nephrology and Hypertension 2001 - 2009
Handled comprehensive management of multi-disciplinary research team and
execution and coordination of multi-center academic trials, inclusive of
pre- and post- award activities, regulatory compliance, and data / sample
management.
. Expanded and developed clinical research infrastructure to accommodate a
mix of NIH, corporate, and internal research projects. Increased
research budget from $700K to $1.6M.
. Achieved laboratory accreditation (CAP) for Glomerular Filtration Rate
(GFR) testing.
. Led Mayo Clinic "Innovations" trip, resulting in strategic expansion of
GFR lab.
. Developed GFR business plan for capital equipment purchase ($25K) to
develop core lab capacity in renal function testing.
. Negotiated a corporate research contract for GFR testing and technical
consulting, resulting in a $250K revenue stream.
. Designed GFR laboratory space and executed move of research personnel and
equipment to Glickman Urologic and Kidney Institute in 2008.
. Developed corporate educational grant revenue ($15K) for Grand Rounds
funding.
. Facilitated researchers in obtaining RPC, CTU, and investigator initiated
corporate research funding ($250K - Wyeth).
Research Coordinator, Radiology - Abdominal Imaging 1996 - 2001
Developed and maintained a comprehensive knowledge of assigned research
protocols and compliant execution of assigned protocols in accordance with
research governing entity requirements, including research sponsor, FDA,
and IRB requirements.
. Implemented utilization of a 3-D renal imaging tool for urologic surgeons
to assist in renal tumor sparing surgery.
. Coordinated administrative functions of abdominal imaging research
trials.
Nurse Clinician II, Gynecology 1987 - 1996
Performed pre-operative H&Ps and preoperative patient instruction, served
as RN first assist (RNFA) for oncologic and routine GYN surgical
procedures, and rounded with physicians postoperatively in hospital,
providing postsurgical care and post discharge instruction.
. Established / performed RN colposcopy for screening of abnormal
(ASCUS) PAP smears.
Staff Nurse Hospital, Urology / Gynecology 1982 - 1987
Performed charge nurse and patient care responsibility for 38-bed unit.
EDUCATION
Master of Science in Nursing and Health Care Management (MSN / HCM), 2012
Kent State University, Kent, OH
Bachelor of Science in Nursing (BSN), 1982
Ohio State University, Columbus, OH
TRAINING
The following training took place at The Cleveland Clinic, Cleveland, OH:
The Cleveland Clinic Leadership Training
High Impact Leadership for Directors
Business Plan Development
Coaching for Outstanding Performance
Business Acumen
Cleveland Clinic Debt and Investment
Process Improvement
Project Management
Medical Philanthropy
Strategic Planning
Marketing and Communications
Innovation in Healthcare
Myers Briggs
Servant Leadership
Crucial Conversations
StrengthFinders
Emotional Intelligence
CERTIFICATIONS
CCRC Certification, 2001 - Present
BLS, 2013
PUBLICATIONS
Herts, B.R., O'Malley, C., Wirth, S.L., Lieber, M., Pohlman, B. (2001)
Power injection of contrast media using central venous catheters:
feasibility, safety and efficacy. American Journal of Roentgenology 176:
447 - 453.
Coll, D.M., Herts, B.R., Davros, W., Uzzo, R.G., Wirth, S.L., Novick, A.C.
(2000) 3D volume rendering of renal masses: Evaluation of a videotaped
display to assist nephron sparing surgery. Journal of Computer Assisted
Tomography April 2000.
Coll, D.M., Uzzo, R.G., Herts, B.R., Davros, W.J., Wirth, S.L., Novick,
A.C. (1999) Three-dimensional computed tomography for preoperative
evaluation and intraoperative treatment of patients undergoing
nephron sparing surgery. Urology 161: 1097 - 1102.
Kennedy, A.W., Salermieri, S.S., Wirth, S.L., Biscotti, C.V., Tuason, L.J.,
Travarca, M.J. (1996) Results of the clinical evaluation of atypical
glandular cells of undetermined significance (AGCUS) detected on cervical
cytology screening. Gynecologic Oncology 63 (1): 14 - 18.
Wirth, S.L. (1996) Nursing screening colposcopy. Synergism 4(1): 2 - 5.
(Cleveland Clinic Foundation Publication)
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