Page *

NIROSHA SRIMATHAN BA, CCRP

RIMATHAN

** ********* *****

Bradford, ON L3Z 0B6

416-***-****

abpgyk@r.postjobfree.com

CAREER GOAL: To obtain a challenging and rewarding position that will allow me to utilize my academic training, skills

and previous work experiences

PROFESSIONAL EXPERIENCE

Clinical Research Coordinator Jan 2009 - Present

Research Analyst Jan 2008 - Jan 2009

Princess Margaret Hospital, University Health Network Toronto, ON

Department of Medical Oncology & Hematology, Breast Clinical Trials Group

Currently providing follow-up for four NSABP trials, two NCIC trials, and actively recruiting for two investigator-

initiated trial and responsible data management for 6 studies

Back up study Coordinator for Four investigator-initiated trial

Screen patients for eligibility by reviewing charts, interview patients and obtain detailed history

Conducts the informed consent process by explaining the purpose of the study and clinical trials procedures

thoroughly to patients, and educated patients about their medications

Coordinates patient visits per study protocol incorporating all aspects of study visit: assessment of adverse

events; monitoring safety and medication; administering questionnaires; collecting, processing and shipment of

samples according to clinical protocol

Maintaining databases for projects and created source documents for data capture

Providing support to the Research Team (Investigators, Manager, Coordinators) in preparation for audits,

reviewing on-site and off-site study charts, regulatory bingers for their completeness per study protocol and

reporting the findings to the manager

Responsible for all ethics submissions and ethics data management to Research Ethics Board

Complete and submit case report forms (CRF & eCRF) to sponsoring agency within time lines

Assists in the modification and maintenance of electronic and paper data management systems; develop source

documentation tools for data collection and study directives; organize and prepare data/charts for monitoring

visits; maintain screening and recruitment databases

Assists with clinical trial budget

Administrative Assistant Nov 2006 Jun 2008

Princess Margaret Hospital, University Health Network Toronto, ON

Department of Medical Oncology & Hematology, Breast Clinical Trials Group

Scheduled and coordinated patients pre and post admission tests, ensured the completion of necessary forms,

notified patients of schedule changes, phoned in prescription orders as directed by physicians

Entered physician orders into Electronic Patient Record including blood work and other diagnostic tests

Arranged small to mid-size formal and informal meetings/events and formal conferences while preparing and

distributing the agendas, notifying parties of the meeting time and location

Liaised with internal and external contacts to arrange meeting rooms, meals, audio-visual and other

equipment/materials, recorded and prepared minutes, memorandums, invoices, prepared table of contents,

indexes, and maintained curriculum vitae of assigned personnel

Performed other related clerical support activities, assembled photocopied, opened, sorted and distributed

incoming mail and other materials for assigned personnel

Page 2

Administrative Assistant Jan 2002 - Jan 2004

Herongate Family Medical Center Ottawa, ON

Family Physician Clinic

Provided support to the clinical team and general office administration, duties included such as answering direct

calls on a multiline switchboard, greeting patients as well as performing some data entry, faxing, filing, patient

record management and billing, booking appointments, patient call backs, appointment confirmations and

referrals

EDUCATION AND ADDITIONAL TRAINING

Clinical Research Associate Graduate Certificate Present - 2012

(Currently Enrolled, Expected to Complete in 2012) Toronto, ON

Certified Clinical Research Professional October 2011

Society of Clinical Research Associates Toronto, ON

Bachelor of Arts in Psychology February 2008

Carleton University Ottawa, ON

Certificates of Completion:

Innovation in Clinical Research, PMH Cancer Program, December 9, 2011

EDC Site Coordinator Training, Medidata University, May 13, 2011

Clinical Research Through Collaboration & Best Practices, PMH Cancer Program, Nov. 2010

Internal Clinical Research Audit Program, October 2008

IntraLinks Safety External reviewer Mandatory v1.0, September 2008

Introduction to Good Clinical Practice (GCP), Investigator responsibilities, Investigator Responsibilities: Informed

Consent, Ethics and the Ethics Research Board, Safety Reporting, August 2008

Tri-Council Policy Statement: Ethical Conduct for research Involving Humans (TCPS), August 2008

Project Specific RDC Training for (Investigator for CRC), July 2008

UHN Principles of Clinical Research Practice, July 2008

The Fundamentals of Clinical Research Level I, June 2008

Privacy within Research, April 2008

Acquiring Date in e-DM for External Study Coordinators, Dec. 2007

PROFESSIONAL RELATED SKILLS

Exceptional organizational skills while abiding by strict timelines

Contributes to the development of guidelines, procedures, and standards

Knowledge of and adherence to GCP and institutional Standard Operating Procedures (SOP)

Developed working understanding of research principles, regulations, and guidelines such as ICH/GCP, Tri-

Council Policy, Declaration of Helsinki and FDA CFR and Health Canada TPP

W orks well using statistical analysis and data management software applications (InForm, Roche's SDE

System, Common Terminology Criteria for Adverse Events v4.0 (CTCAE) and NSABP online data entry)

Proficient in the use of Microsoft Office, Excel, Word, Internet, UHN Intranet, Electronic Patient Record (EPR)

and Pathways Healthcare Scheduling (PHS)

Current member of cooperative groups, NCIC CTG and NSABP

SoCRA member

References shall be made available upon request

Contact this candidate