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Clinical Research Project

Location:
Brampton, ON, Canada
Posted:
October 18, 2018

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Resume:

Ruella DCosta Fernandes

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

Brampton, ON L6R 1X9

647-***-****

ac7e9f@r.postjobfree.com

Hello!

I am writing to you on the open position of a Research Coordinator at your organization. My objective is to be part of a diversified work environment to learn, adapt and better myself to the challenging role provided by your organization.

I have been in the Healthcare Service Industry for the past 07 years as a Clinical Research professional with a Masters in Clinical Research with experience ranging in the following fields - Bioequivalence Studies, Medical Writing, Pharmacovigilance & Clinical Trials. I do have the ability to take on profiles to manage tasks within the Healthcare industry as I have extensively dealt with Clientele Management, Vendor Management and Inter-departmental coordination. My skills include Project Management, Microsoft Office, Problem Solving, Adaptability, Social and Strong Work Ethic. I have had managerial experience with handling a team of project executives and medical writers as well.

Enclosed is my resume that more fully details my background and work experience. I thank you for your time to consider me for the said position. I would love to have an opportunity with your organization and help achieve its goals.

Thank you in advance for your consideration.

Kind regards,

Ruella DCosta Fernandes

RUELLA DCOSTA FERNANDES

Clinical Research Professional

87 Dandelion Road, Brampton ON L6R 1X9

Cell: 647-***-**** ; Skype: ruella.dcosta

Email : ac7e9f@r.postjobfree.com

Linkedin Profile: linkedin.com/in/ruella-dcosta-fernandes-261ba225

PROFESSIONAL HIGHLIGHTS

7 years experience in the Healthcare Industry (Pharmaceutical & Clinical Research Organizations)

Managed a team, worked as a team player as well as independently

Computer literate using software tools such as Microsoft Office (Outlook, Word, Excel, PowerPoint)

Excellent communication, organizational, decision making, interpersonal, negotiable,leadership skills

Multi-tasker with attention to detail, proactive, adaptive and excellent task follow through

EMPLOYMENT HISTORY

VERGO CLINICALS Feb 2015 - Jul 2018

Assistant Manager - Project Management & Medical Writing

Managed a team of Project Executives and Medical writers comprising of Protocol & Report writers.

Achieved high Clientele relationship including client quotations and project agreements, coordination with Sponsor/Client for stipulated timelines and study progress from initiation until completion.

Followed up between inter-departments to monitor the overall study progress; planned study schedules and project trackers for study development.

Regulatory submissions included ‘Bioequivalence No Objection’ and ‘Import License’ application to Drug Controller General of India (DCGI), Ethics Committee Submissions and Approvals.

Literature search for project feasibility; Protocol and Informed Consent Document, Study Report (including eCTD format) for DCGI, ASEAN, Japan, MHRA, EMEA, Health Canada & USFDA .

Developed Standard operating Procedures (SOPs), Case Report Forms (CRFs) and Trial Master Files (TMFs).

Cleared inspections for NPRA (National Pharmaceutical Regulatory Agency, Malaysia), MHRA (Medicines and Healthcare products Regulatory Agency, UK) and World Health Organization (WHO)

COGNIZANT TECHNOLOGY SOLUTIONS Jul 2014 – Jan 2015

Data Analyst

Quality control on calls for adverse event reports, product quality complaints and medical inquiries to ensure information reported by clients are routed to specific departments.

Adverse event monitoring, reporting and their corresponding Call Detail Record as per the Standard Operating Procedures.

ROCHE PRODUCTS PRIVATE LIMITED Nov 2012 – Jun 2014

Drug Safety Officer

Adverse event reporting (ArisG software) and Safety reporting as per Schedule Y format reported to Regulatory authorities.

Supported internal Pharmacovigilance Audit for activities including SAE Submissions, Local Reporting Requirements (Single Case Processing & Management), Management of External Service Providers (CROs), Drug Safety Communications with Business & Sales, Management of Safety in Compassionate Use, Clinical Studies & Post Marketing Surveillance, Safety Filing & Archival Management.

Analyzed medical and scientific literature searches, clinical trial & bioequivalence protocols using critical judgment and scientific expertise to support projects or queries.

Training conducted on Safety Reporting Processes and ARIS application to Safety Personnel.

Generated Annual Safety Updates, Periodic Safety Reports (PSURs), Reconciles SAEs in accordance with project specific guidelines and Represents team at client meetings.

Customization of Pharmacovigilance Agreements between Sponsors and Vendors.

IQVIA Apr 2011 – Oct 2012

Clinical Trial Assistant

Quality Check and File reviewed for Documents, Receipt and completeness and accuracy of administrative documents, Shipment of study materials, Filing & Tracking of Regulatory documents.

Compiled and reviewed in-house files for all studies / projects and assisted the project team by providing requested documents during Audits/Inspections for SOP, ICH and GCP compliance.

Accompanied Clinical Research Associates on Observational Site visits for Reconciliation of Investigational Product Accountability & Site Master File evaluation.

Attended project meetings to record minutes for the same and coordinated with Clinical Team Leader and other team members for related queries.

EDUCATIONAL QUALIFICATION

Degree

University

Year of passing

Place

Masters in Science (Clinical Research)

Cranfield University

2011

Bedford, UK

Bachelor’s in Pharmacy

Rajiv Gandhi University of Health Sciences

2009

Bangalore, India

The above Degree’s were evaluated by World Education Services of Canada (WES) in 2017 and recognized as Canadian equivalency level of a Master’s Degree and a Bachelor’s Degree (Four Years) respectively.

REFERENCE : Will be provided upon request.



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