Sandra Lynn Pacheco

3 Safari Court

Brampton, Ontario L7A 1G7

Phone:  (905) 840-3356, Cell:  (416) 894-3446

E-Mail:    [email protected]

SUMMARY:

Diligent, detail-oriented Administrative Assistant with 23 years of experience in the pharmaceutical industry with a strong knowledge of GCP and ICH guidelines.  Strong organizational skills; ability to prioritize and excels at managing multiple tasks and multiple studies in a fast-paced environment.   Works well under pressure and demonstrates reliability, honesty and integrity.  Assigned tasks and duties are completed efficiently, enthusiastically and within project timelines.

EMPLOYMENT HISTORY:

September 2016 – January 2018                              Novo Nordisk Canada

POSITION:                                                      Clinical Trial Coordinator

·        Support Clinical Trial Managers and Clinical Research Associates as required to meet project timelines.

·        Prepares essential regulatory trial documents (e.g. Protocol Signature Page, Financial Disclosure Form, QIU, during start-up and Protocol Amendments and adhere to Health Canada requirements and Novo Nordisk SOPs to complete Greenlight process for Principal Investigator Site Activation.

·        Establishes and maintains communication with external site staff (Principal Investigators and Study Coordinators) by providing responses to questions specific to essential regulatory document completion and collection to meet timelines and SOP requirements.

·        Responsible for STMF by collecting, reviewing content, completing, ensuring accuracy, filing and uploading documents to novoDOCS.

·        Monitors and maintains non-drug trial thresholds by analyzing remaining stock on a regular basis to maintain adequate supply levels for ongoing site distribution.

·        Adhere to reporting timelines by completing system training (IMPACT, CATS, CONCUR) and timely entry of IMPACT fields to meet monthly quality checks.

·        Control and maintain Novo Nordisk Canada and/or external trial staff (Principal Investigators, Study Coordinators and site staff) accesses to essential clinical trial computer systems (IVRS, EDC, ShareFile and other vendor systems as required).

·        Prepare quarterly site payments.

January 2016 – September 2016               PRA Health Sciences (dedicated to BAYER)

POSITION:                                                      In-House CRA II – Clinical Trial Site Coordinator

·        Support Study Team and Clinical Trial Monitors.

·        Actively assist in setting up sites (accounts and contacts) in the Clinical Trial Management System (IMPACT).

·        Create study start-up tools, which include compiling all documentation, required for Investigator Site Files for site initiations.

·        Handle all document requests from sites and Clinical Trial Monitors.

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·        Assist in the ordering/distribution of study-related supplies.

·        Coordinate and maintain the contact details of the study team, including distribution lists.

·        Responsible for tracking and filing documents in the TMF (paper-based files) and uploading documents to the eTMF.

·        Responsible for sending out and tracking Clinical Trial Agreements.

·        Attend all LSIT Meetings and prepare and distribute Minutes to Study Team.

·        Develop and maintain functional knowledge of GCPs, SOPs, local regulations and therapeutic area(s) through continued training provided by the local training and compliance department to ensure patient safety and data integrity.

November 2014 – January 2016               QUINTILES – In collaboration with Hoffmann-La Roche Ltd.

POSITION:                                                      Senior Clinical Trial Assistant

August 2011 – November 2014                 HOFFMANN-LA ROCHE LIMITED

POSITION:                                                       Country clinical Trial Assistant

·        Train and mentor new CTA’s hired for Quintiles – in collaboration with Hoffmann-La Roche Ltd. Global Functional Resourcing.

·        Support Country Study Managers, Country Study Specialists, Study Start-up Specialists and Clinical Trial Monitors for both Canada and US.

·        Create Confidentiality Agreements for sites during feasibility process.

·        Prepare all regulatory documentation for study start-up (includes Financial Disclosure Forms, FDA 1572, Authorization Forms, QIU, REBA).  Send regulatory documents to sites, communicate with sites, collect regulatory documents and review files for accuracy and completeness.

·        Actively assist in setting up sites (accounts and contacts) in the Clinical Trial Management System (CTMS).

·        Create study start-up tools, which include compiling all documentation, required for e-Investigator files and Pharmacy binders for site initiations.

·        Prepare CTSI and submit to Regulatory Department.

·        Handle all document requests from sites and Clinical Trial Monitors.

·        Assist in the ordering/distribution of study-related supplies.

·        Coordinate and maintain the contact details of the study team, including distribution lists.

·        Attend all LSIT Meetings and prepare and distribute Minutes to Study Team.

·        Develop and maintain functional knowledge of GCPs, SOPs, local regulations and therapeutic area(s) through continued training provided by the local training and compliance department to ensure patient safety and data integrity.

Jan. 2011 – July 2011                     FUNDEX INVESTMENTS INC. (THE DUGGAL GROUP)

POSITION:                                       Administrative Assistant to Financial Advisor

·        Reviewed and responded to requests and queries from clients in an efficient and timely manner.

·        Maintained record of responses / transactions in the ACT database and/or client files.

·        Scheduled meetings with clients and prepared all pertaining documents for the meeting.

·        Updated database by entering meeting minutes with the client.

·        Updated dealer’s database with current information.

·        Compiled and created new account applications, fund company applications and order entry forms and faxed to fund companies and dealer in a timely manner.

·        Provided liaison coordination where required between client groups and the fund companies.

·        Processed buys, switches, redemptions for clients in the UNIVERIS System

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2002 – 2010                                     NOVARTIS PHARMACEUTICALS CANADA INC.

POSITION:                                        Quality Assurance Administrative Assistant

·        Provided confidential and administrative support to Director QA and the QA department on a variety of secretarial and administrative duties including preparation of presentations, mail and ordering of office supplies.

·        Ensured all SOPs were revised within the 3-year revision period and controlled the SOP distribution.

·        Filed training records for the department and ensured that these were updated in the Training Matrix.

·        Coordinated new associates on-boarding and ongoing needs (computer, telephone, credit card, cell phone, security card, business cards, training supplies etc. Provided training where required.

·        Filed and archived GMP documents as required ensuring that all archived records are traceable.

·        Ensured that revised Packaging Directions, Manufacturing Directions, Control and Stability documents are filed and updated in the Product Master List.

·        Coordinated and booked travel arrangements for the Director and Associates.

·        Issued Purchase Orders, Amendments and Cheque Requisitions.

·        Prepared expense reports.

·        Coordinated individual staff and departmental meetings.

·        Reported monthly absence and vacation report for department.

·        When necessary organized and coordinated teleconferences and offsite meetings.  Assisted with Agenda preparation and recording minutes.

·        Entered minor complaints into Global GCRS database.

·        Updated all “Controlled Lists” and distribution of approved documents.

1991 – 2002                                     SCHERING-PLOUGH HEALTHCARE PRODUCTS CANADA INC.

POSITION:                                        Quality Control & Regulatory Affairs Administrative Assistant

·        Provided administrative support to Director, 1 QA Inspector and 3 QA lab technicians.

·        Prepared all expense reports.

·        Coordinated and booked travel arrangements for department

·        Provided Material Safety Data Sheets and Ingredient Listings to customers.

·        Maintained Customer Complaint program.

·        Maintained Absence & Vacation database.

·        Revised SOP’s and distribution of such.

·        Ordered office supplies for department.

1990 – 1991                                      DIGITEC TELECOMMUNICATIONS

POSITION:                                        Receptionist

·        Answered all incoming calls.

·        Typing of all correspondence.

·        Arranged for courier pick-up.

1988 – 1990                                      GREENSPOON BROS. DEMOLITION

POSITION:                                        Receptionist

·        Answered all incoming calls.

·        Typing of all quotations and contracts.

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1986 – 1988                                      EURODESIGN FURNITURE

POSITION:                                        Receptionist

·        Answered all incoming calls.

·        Arranged for courier pick-up.

·        Receive orders from customers by telephone and fax.

·        Type up all orders.

EDUCATION:

High School Graduation Diploma – 1984, WJ Fenton Secondary School

Hairstylist Diploma – 1985, Art & Technique Hairstyling School

COMPUTER PROGRAMS:

Microsoft Office (Word, Excel, PowerPoint, Outlook), Clinical Trial Management System (CTMS), Learning Management System (LMS), Google Mail, Lotus Notes, UNIVERIS, ACT, IMPACT, eTMF

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