Download 57cc5fb921182__Nida Shafique_CV_May

Nida Shafique
83-A Ali Town,Raiwind
Road, Lahore, Pakistan
Mobile no.+92-342-3566733
Email: [email protected]
OBJECTIVE
To acquire a responsible and challenging job using my work experience, qualification and to excel my career in
a dynamic and progressive organization for the achievement of mutual goals and excellence.
ACADEMIC QUALIFICATION
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CCRP (Certified Clinical Research Professional Diploma)
Kriger Research Center, Asia Pacific Region
2011
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Pharm-D
Federal Urdu University
3.63/4.0 GPA
2010
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Intermediate
St-lawrance Govt. girls college
1st division
2004
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Matric Science
Pioneer Academy
1st division
2002
PROFESSIONAL EXPERIENCE
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Ferozsons Laboratories Pvt. Limited
Designation: Clinical Research Associate
Feb-2015 – On-going
Metrics Research (Pvt.) Ltd.
Dec 2012 – Dec 2014
Designation: Senior Clinical Research Associate
Job Responsibilities
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Liaise with doctors, consultants and investigators conducting clinical trials.
Manage regulatory authority applications and approvals.
Responsible for the management of designated clinical trials including investigator selection, analysis of
potential patient recruitment, preparation of trial related documentation (protocols, Case report forms,
inform consent documents, letters of agreement, confidentiality agreements), organising ethics
committee submissions.
Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities
are used.
Monitoring the assigned clinical trial following company SOPs and in accordance with GCP / applicable
regulatory authority.
Planning the requirements for clinical trial material, ordering clinical trial material (head office or local
comparators), setting up and monitoring the systems
Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion
criteria for ongoing trials.
Participate in global conference calls to review progress of ongoing clinical trials.
Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the
database. Ensure that queries generated during cleaning are responded in a timely fashion.
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Manage patient recruitment strategies to increase patient randomisation into the trial (e.g. Investigator
and research nurse meetings, update newsletters, letters to GPs).
Review all SAEs, ensure Investigator sign-off, that sites are notified and that all company procedures
are complied with.
Maintain project files including but not limited to: ethics committee approvals; curriculum vitae of
investigators and study personnel; clinical investigators brochure; protocols; case report forms
instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance
documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and
schedules of payment.
Participate in departmental planning sessions, and SOP development.
Provide management to the clinical research assistants to ensure that their role and contribution is
optimised
BioPharma Metrics Inc.
Jan 2010 – Jan 2012
Designation: Pharmacist
Job Responsibilities
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Review the study protocol for specific study requirements prior to the preparation of pharmacy
document and drug dispensing.
Receive, prepare and retain study drugs according to study protocol, sponsor and/or applicable
Standard Operating Procedures.
Request the randomization scheme from Medical Writing/Document Control department. Maintain
the hardcopy of the randomization scheme and follow the blinding procedures outlined in the
SOPs.
Interact with Project Management team in regards to the study drug shipment, discrepancies and
drug retentions.
Responsible in training staff members in assist of drug dispensing and reconciliation.
Establish and maintain policies and procedures regarding drug preparation and distribution
according to GCP and company SOPs.
Maintain restriction to Pharmacy area.
Write and/or revise SOPs as required in accordance to the GCP/ICH, FDA or applicable regulatory
regulations.
Facilitate pharmacy tour/orientation where required.
Maintaining all pharmacy equipment and records.
Dispose/destroy expired drugs and retention of study drugs.
Participate in clinical meetings and training sessions as required.
BioPharma Metrics Inc.
Jan 2010 – Jan 2012
Designation: Clinical Research Coordinator
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Responsible for monitoring of BE (Bio-equivalence) study activities.
Coordinate all study activities to ensure protocol and regulatory requirement(s) are met (e.g.
sample collection, sample processing, clinic set-up, etc.)
Protocol Training for clinical research staff.
Obtain Informed Consent as appropriate.
Compliance check on subjects.
Adverse Event Reporting and Serious Adverse Event reporting to appropriate departments(s).
Maintain study files for each clinical trial and completion of Case Report Forms.
Write and/or review source documents forms.
Write and Revise SOPs, internal procedures and ensure the accuracy of generated data in
accordance with protocols, ICH, GCP and applicable regulatory agencies.
Maintain adequate, accurate, complete and legible records.
Provide study updates and statistic reports to management (e.g. study update, month end report).
Responsible for remaining current with regulatory requirements (DRAP, TPD, FDA, EMEA etc.)
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 Platinum Pharmaceutical (Pvt) Ltd
Apr 2010 - May 2010
Internee Pharmacist
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Brief introduction on GMP, environmental health and safety, In-process unit, product planning and
inventory control, packaging inspection unit.
Rotations in raw material analysis lab, production areas, product development and monitoring lab,
chemical lab, microbiological lab.
AREA OF EXPERTISE
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Clinical Trial Experience: Gastrointestinal disorder (Gastric ulcer), Virology (Hepatitis C), Oncology
(Breast cancer: early and metastatic), Infant lactose intolerance study.
Bioequivalence and Bioavailability experience: Depression, erectile dysfunction, pulmonary
hypertension, schizophrenia, and insomnia in healthy volunteers.
Pre-Clinical, Phase III and IV.
Protocol development
Case Report Form / Source document template preparation
ISO 9001 – 2008 Quality Management System
Quality Assurance
Ethics in clinical research
International conference on harmonization guidelines (ICH)
Good clinical practice (GCP)
Regulatory requirement; FDA and drug control, drug and cosmetic Act,DRAP
Investigational new drug application (IND), New drug application (NDA)
Monitoring pre-study visit, site initiation, interim visit, site close out.
SOP development
Pharmacovigilance
Clinical study report (CSR)
e-CRFs e.g. Oracle, Amedon software
IWRS (Interactive Web Response System) – S-Clinica software
Clinical Trial Management System (CTMS)
Strong Interpersonal and communication skills
Ability to work independently
Strong management skills
Microsoft office proficiency
Internet browsing
COURSES / CERTIFICATION
 Good Clinical Practice (GCP) certification from BioPharma Services Inc, Canada team.
 One month internship at JPMC (Jinnah Postgraduate Medical Center) in different ward as clinical
pharmacist.
 Applied Pharmacy Practice Course (APPC) from ASK development organized by USAID (United States
Agency International Development).
 Registered as a Pharmacist in Pharmacy Council of Sindh.
PERSONAL PROFILE
Father's Name
Date of Birth
Religion
Marital Status
Language
Muhammad Shafique
Nov 24, 1986
Islam
Married
English, Urdu
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EXTRA CURRICULAR
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Attended single topic conference on “Hepatitis C Virus care and cure”organized by APASL (Asian
Pacific Association for the Study of the Liver) on 17-Oct-2014 - 19-Oct-2014.
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Attended Clinical Trials Symposium on “Clinical Trials in Pakistan: Bridging Gaps & Building
Networks”organized by Aga Khan University, Karachi on February 20 – 21, 2014.
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Attended seminar on “Disaster Management”organized by Pakistan Medical Association and
Pharmacy Graduate Association on 31-August 2013.
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Participated in the seminar on strength the role of pharmacist in drug abuse prevention.
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Participated in FUUAST HEALTH MELA organized by Department of pharmacy.
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Participated in the seminar on Diabetes and its hazardous effect on different organ (World Diabetic day)
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Awarded as best Compere in Pioneer Academy School.
 Awarded as best conductstudent in Pioneer Academy School.
EXTRA CURRICULA
REFERENCE
Furnish upon request.
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