Manager Project

Inna V. Mudrova, BSN, CSCR, MS

**** **** ** **** * Philadelphia, PA 19115 ** ******@*****.*** ** 267-474-

2809

Education:

Master of Science in Clinical Research Organization and Management,

12/2010

Post-Bachelor's Certificate of Study in Clinical Research, 05/2009

Drexel University, Philadelphia, PA

Bachelor of Science in Nursing, 05/2007

Widener University, Chester, PA

International Club, President

Model European Union

Phi Beta Delta, Honor Society for International Scholars

Professional Awards/ Trainings:

November 2009 Research Operations (RO) Monthly Service Award, RPS,

Inc., 12/2009

CRA Grooming, PAREXEL Intl., Fall 2008

Co-monitoring: Site Initiation Visits, Routine Monitoring Visits,

Close-Out Visits

Overview of Drug Development, Drug Information Association (DIA), 03/2008

Therapeutic Area of Experience:

Neurology, ophthalmology, cancer, endocrinology, infectious disease,

pulmonary, cardiology

Research Experience:

Senior Study Start-Up Specialist, ReSearch Pharmaceutical Services Inc.,

Fort Washington, PA, 10/2009- Present

Coordinate and manage the completion of regulatory and contractual

documents that ensures timeline and quality targets are met; oversee

creation, distribution and tracking of investigator feasibility

questionnaire; Review and edit ICF's for completeness and accuracy;

submit completed regulatory packets to IRB; attend Investigator Meetings;

monitor, identify and implement new regulatory strategies and

requirements; assist in formulation of strategic initiatives and works

with functional management to develop implementation plans.

In-House Clinical Research Associate/Clinical Research Assistant, PAREXEL

International, Waltham, MA, 08/2008- 10/2009

Coordinated and performed in-house monitoring activities as related to

the conduct of the clinical trials; participated in conducting site

visits as a part of clinical team. Provided services for the collection,

review, maintenance, and tracking of regulatory documentation: 1572s,

ICFs, monitoring reports, PIs Signatures, PDs in CIMS and Central Files

for Phase III studies, ensuring compliance with FDA regulations as

related to GCP guidelines, and Company Standard Operating Procedures

(SOPs).

Clinical Project Associate, Bio-Imaging Technologies Inc., Newtown, PA,

02/2008- 08/2008

Established clear and measurable project goals, defined timelines,

milestones and limitation; led project meetings, conference calls, and

training calls on Imaging Guidelines; researched and responded to client

inquires; reviewed and edited start up documents, Communication Plan,

Specific Project Work Instructions; performed project analysis and

management; oversaw project budget.

Other experience:

Property Manager, Self-Employed, Philadelphia, PA. 02/2008- Present

Budget oversight by understanding financial statements, profit and loss,

income taxes; maintain relationships with contractors and repair

companies, budget capital expenditures, and monitor the quality of all

repairs and maintenance; managing tenants; maintaining the condition of

the properties: landscaping, electrical, plumbing, roof, walls,

appliances.

Commercial Manager, Moscow, Russia. 05/1999- 09/2001

Budged oversight; pre-planned and wrote/edited contracts and leases;

monitored of concession contracts; development of business opportunities;

coordinated different media formats (television and web-based).

Nursing Experience:

Psychiatric Nurse, Montgomery Crisis Emergency Services, Inc.,

Norristown, PA, 08/2007- 02/2008

Assessed and dealt with patients' problems relating to emotional and

medical health; observed and recorded the significant observations on the

nursing flow chart; provided crisis intervention services along with

supportive counseling; poured and administered various medications while

coordinating efforts with multidisciplinary treatment with hospital wide

departments.

Nurse Extern, Oncology, Jefferson University Hospital, Philadelphia, PA.

10/2006- 04/2007

Assisted residents with dressing, bathing oral hygiene and related

personal care. Observed residents to report physical and behavioral

symptoms to medical personnel in charge. Took and recorded resident's

blood pressure, temperature, pulse, respiration and weight. Made routine

entries into residents' charts.

Nurse Intern, Independent Blue Cross Internship, Philadelphia, PA.

06/2006- 08/2006

Shadowed Nurse Practitioners during clinic visits with patients.

Participated in the collection of patients' full medical histories,

patient education and writing prescriptions under Doctors' supervision.

Computer Skills:

Software: Lotus Notes, CIMS, Microsoft Office (word, excel, power point,

outlook), Word Perfect, IMPACT, TrackWare

Language Skills:

Fluent in Russian, conversational French and Spanish.

Reference:

Available upon request.

Contact this candidate