SASHA NORORI

*** ******* ****** ****. *******, ON, L6B 1M1 M: 647-***-**** acqaau@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Comprehensive knowledge of the Clinical Trial Process

Extensive experience (~9 years) working in CROs

Experience and knowledge in project management, clinical trial monitoring, preparation of abstracts and posters, quality control, study drug handling processes and data management

Ability to design, implement and amend clinical trial protocols

Excellent negotiation and decision making skills

Resourceful, efficient and focused with excellent attention to details

Excellent knowledge of regulatory aspects of clinical trials

Demonstrated knowledge of GCP,ICH, and FDA guidelines ; GCP certified

Excellent interpersonal and communication skills

Strong critical thinking and problem solving skills

EDUCATION

2009 - 2010 : University of Manchester: MBS, UK

Graduate, Masters of Science

Healthcare Management Thesis: The Case of SARS in Toronto: Impact, Responses and Lessons Learned to Inform Public Health Policy.

2004 - 2009: University of Toronto, Canada

Graduate, Honours Bachelor of Science

Cell & Molecular Biology Co-op Specialist Program

PROFESSIONAL EXPERIENCE

Jun 2012 - present: Ozmosis Research Inc., Toronto, ON

Clinical Trials Manager

Successfully managed Phase I and III trials with over 10 sites each and >200 patients on each, for major Pharma clients within tight deadlines

Responsible for development, coordination, data and project management of Phase I, II and III clinical trials from pre-study to activation, follow-up and trial closure

Responsible for negotiation of budgets with the Sponsor and sites and approval of payments to sites

Collaborate and assist the sponsor with the development and writing of protocols/amendments and review.

Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options and, development of recruitment strategies to increase patient randomization into the trial

Tracking of study milestones both for the overall study as well as each site so that appropriate disbursements and/or decisions regarding the trial are facilitated

Liaise between site and sponsor to ensure that all trial related documentation and information is communicated to all staff involved and that study-related issues are addressed in a timely manner

Compile and record documents that are to be submitted to regulatory agencies (e.g. Health Canada CTA), sponsors and/or pharmaceutical companies in accordance with Health Canada, FDA, ICH-GCP and IRB/REB regulations

Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.

QA reviews of internal study documents and submission of audit reports to relevant staff for resolution

Conduct central monitoring of CRFs where required as per the monitoring plan in accordance with Ozmosis standard operating procedures

Organize and present at Investigator Meetings and Study Initiation visits, as required

Conduct on-site review of the TMF to assist clinical sites with audit preparation activities, as required.

Responsible for oversight of the database build process (for eCRFs) and maintaining systems for effective data flow

Collaborating with relevant site staff to improve the quality of data by ensuring consistency and compliance with the protocol

Final review of CIOMS reports for reportable Serious Adverse Events

Involved in the development of templates, forms and general guidelines for day to day activities

Provide study-specific training for staff members and clinical sites.

May 2011 - Jun 2012: BioPharma Services Inc., Toronto, ON

Senior Clinical Research Coordinator

Responsible for coordinating and monitoring all study activities in accordance with protocol and regulatory requirement(s)

Successfully conducted 21 Clinical studies from planning to daily operations to project close-out within a year

Provided Protocol Training for clinical research staff

Reported Serious Adverse events to the Sponsor

Supervised the collection, handling and processing of PK samples

Supervised, administered and/ or assisted in drug administration

Maintained study files for each clinical trial and completed Case Report Forms

Met deadlines according to project timelines

Developed and/or reviewed source document forms

Responsible for oversight of inventory, storage, and record keeping of study drug(s)

Assisted in dispensing study drug(s)

Developed and Revised SOPs, internal procedures and ensured the accuracy of generated data in accordance with protocols, ICH, GCP and applicable regulatory agencies

Provided study updates and statistic month end reports to management

Responsible for remaining current with regulatory requirements (TPD, FDA, EMA, etc.)

Jul 2010 - May 2011: Kendle Early Stage (now INC Research), Toronto, ON

Clinical Research Associate

Provided support to clinical research studies by administering pharmacodynamic testing, subject training or other measures as appropriate

Completed Case Report Forms (CRFs) / electronic Case Report Forms (eCRFs) and User Acceptance Tests (UAT)

Assised study team with implementing plans for study conduct

Ensured quality and accuracy with information provided to subjects

Ensured environment used for pharmacodynamic testing is optimal

Verified pharmacodynamic equipment meets study requirements

Maintained applicable study logs to support conduct of study

Assisted with resolving discrepancies with source documents and follow up until resolution in a timely manner.

Active member of the Health and Safety Committee.

Nov 2007- Sep 2009: Kendle Early Stage (now INC Research), Toronto, ON

Clinical Recruiting Specialist

Participated in Protocol review process

Assisted management in organizing recruiting strategy to ensure a full panel for every study

Developed study specific/generic telephone screens within established timelines

Conducted subject recruitment for Phase I studies and Abuse Liability Studies by determining eligibility via inclusion/exclusion criteria

Ran database searches and implemented recruiting strategies, i.e. marketing through media

Registered potential subjects into the recruiting database and provided study-specific information

Provided metrics on advertisement performance and recruitment activities

Coordinated and confirmed appointments with potential subjects

Informed management in a timely fashion of potential problems in recruitment.

May 2006 - Nov 2007: Pharma Medica Research Inc. Toronto, Ontario

Medical Recruiter/ Screening Receptionist

Created new subject files and recruited subjects using Clinic Subject Eligibility Database system

Maintained confidentiality while creating subject records

Booked eligible subjects for studies and perform inter-study transfers

Telephone screened subjects to determine eligibility in clinical trials, following GCP, ICH guidelines

Provided subjects with accurate information about clinical studies

Prepared screening packages and related materials and photocopying as required, adhering to SOPs

Followed privacy policy when disclosing medical results to subjects

Performed screening audits to ensure accuracy of information

Updated subject files as needed regarding medical history and other personal information

Properly completed documentation of clinical activities according to GCP, SOP guidelines and/or FDA/TPD regulation

Verified subject identification and followed appropriate check-in procedures

Followed Joint Health & Safety rules and regulations at all times.

PUBLICATIONS AND PRESENTATIONS

oEHA Conference Abstract. C. Chen et. al. 2014. ANTI-TUMOR ACTIVITY OF SELINEXOR (KPT 330), AN ORAL SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE), DEXAMETHASONE IN MULTIPLE MYELOMA PRECLINICAL MODELS & TRANSLATION IN PATIENTS WITH MULTIPLE MYELOMA

oPoster Presentation of the above at ASH. C. Chen et. al. 2014. SELINEXOR (KPT 330) DEMONSTRATES MARKED SYNERGY WITH DEXAMETHASONE (SEL-DEX) IN PRECLINICAL MODELS & IN PATIENTS WITH HEAVILY PRETREATED REFRACTORY MULTIPLE MYELOMA

oEHA Conference Abstract. J. Kuruvilla et. al. 2014. THE ORAL SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE) SELINEXOR (KPT-330) ACTIVITY IN DOUBLE HIT DIFFUSE LARGE B CELL LYMPHOMAS (DLBCL) IN PRECLINICAL MODELS & CLINICAL ACTIVITY IN PATIENTS WITH DLBCL

oPoster Presentation of the above at ASH. J. Kuruvilla et. al. 2014.. THE ORAL SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE) SELINEXOR (KPT-330) DEMONSTRATES BROAD AND DURABLE CLINICAL ACTIVITY IN RELAPSED/REFRACTORY NON-HODGKIN’S LYMPHOMA

oEHA Conference Abstract. R. Garzon et. al. 2014. A PHASE 1 DOSE ESCALATION STUDY OF THE ORAL SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE) SELINEXOR (KPT-330) IN PATIENTS (PTS) WITH RELAPSED / REFRACTORY ACUTE MYELOID LEUKEMIA (AML)

PROFESSIONAL AFFILIATIONS

Member of Society of Clinical Research Professionals (SoCRA)

REFERENCES AVAILABLE UPON REQUEST

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