B AR I RA MA L I K

Franklin Park, New Jersey.

Cell: 609-***-****

barira.malik @gmail.com

P rofessional Summary

• US qualified BSC with 3 years of hands-on clinical research experience.

• Excellent understanding of clinical research documentation & methodology, medical

terminology, FDA and GMP, GCP/ICH guidelines.

• Strong negotiation and communication skills with the ability to operate effectively in Global

pharmaceutical environment.

• Attention to detail and quality focused with strong organizational and project

management skills

• Excellent understanding of physiology, pharmacology, clinical study objectives,

pharmacovigilance activities and overall drug development process.

• Therapeutic Areas: Oncology, Rheumatology, Immunology

P rofessional Experience

Johnson and Johnson, (Medical Affairs)

Clinical Research Associate I

D ec 2013- Present

• Focus on investigator initiated studies, Phase III - Phase IV trials, and registries to ensure

key activities related to safety and reporting are executed in a timely and compliant

fashion.

• Partners with Clinical Project Scientists, therapeutic area leaders, Global Clinical

Operations staff, and key safety personnel to execute Medical Affairs research initiatives.

• Assists with execution of clinical studies, preparation of internal/external presentations,

study tracking, and analysis.

• Coordinate, manage and organize data collection for internal meetings

• Operate Ariba P2P to maintain budgetary responsibilities.

• Working in collaboration with the therapeutic area leadership as well as the Centers of

Excellence to act as a liaison between the Janssen Medical Affairs research group and

operational counterparts within J&J to achieve successful implementation of projects

through in-sourced, outsourced or matrix operating models

• Coordinate, manage and organize data collection for internal meetings

• Collect and review regulatory documentation

• Perform regulatory background check for HCP to initiate investigator studies

• Operate Ariba P2P to maintain budgetary responsibilities.

• Review and enter data into databases

Pfizer Pharmaceuticals Inc.

Senior Associate Scientist Nov 2012- Nov 2013

• Primarily responsible for developing analytical methods and/or bioassays for vaccines,

proteins or other therapeutic entities

• To monitor the intended mechanism of action of drug candidates and to confirm residual

host impurities are controlled.

• Work across analytical functions and projects and provide technical counsel to other

organizations and senior leadership

• Developing an indirect Cell based ELISA to determine the potency of a drug substance.

• Enter applicable information into the global safety database for initial or follow up cases

received via paper, fax or email.

• Responsible for safety data/Adverse Events entry and case book in onto adverse event

database (ARGUS) and QC of adverse events for completeness, accuracy and

appropriateness for expedited reporting.

• Monitor electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse

Event (AE) Reports

• Assist with the monitoring of safety profile of assigned projects, co-ordinate and assists

with pharmacovigilance activities through active follow-up of AE/SAEs.

• Interface with safety team for safety matters including follow-up on events of interest and

input into site queries regarding adverse events.

Celgene Cellular Therapeutics.

Clinical Associate (Research and Development) Mar 2011- Oct 2012

• Supports Global trial leader and clinical scientist for Phase III study submission

related activities.

• Review Patient profiles for data verification/cleaning before database lock.

• Raising queries in OC/RDC and keeping track / resolving those generated queries.

• Reconciliation of SAE’s before Database lock.

• Involved with the Adjudication of SAE’s to evaluate overall safety of the

molecule in collaboration with Medical Review Committee.

• Involved with TMF Reconciliation for Clinical Study Report.

• Develop and maintain collaborative working relationships with clinical

investigative sites and study clinicians to get supportive documents as required.

SNS Research, Lakewood, NJ

Clinical Research Coordinator, Jun 2010- Feb 2011

Involved in Informed Consent process and prescreening of patients in data base and

•

scheduling patients for screening. Following the sponsor’s and site’s SOP under GCP and

FDA guidelines.

Submitting documents to IRB and following up with IRB queries/ recommendations.

•

Answer specific queries by IRB (Institutional Review Board) regarding, Protocol, ICF

•

etc. for approval.

• Entering data in CRF’s (paper) and or EDC (Electronic Data Capture).

• Assist Principal Investigator with the evaluation of a study by reviewing study data.

Identifying and resolving data discrepancies.

• Review the tracker maintained by CRO/Sponsor for Open Notes, pending queries, SAEs

and AE's.

• Review, analyze adverse events and enter on CRFs/EDC using CTCAE (Common

Terminology

Criteria for Adverse Event) to properly code the adverse event and use of proper grade associated

with each adverse event.

• The completion of full case information (SAE) on the database, culminating in Quality

Review to ensure accuracy and completeness.

• Perform the collections and maintenance of essential study documents at the site and

regular documents which includes PI/subPI, CVs and 1572.

UMDNJ Pediatric Rheumatology, New Brunswick, NJ

Medical Assistant, September 2008- March 2009

• Recorded medical tests and lab reports

• Prepared and filed patient charts and performed data entry

EDUCATION

• Bachelor of Science in Biotechnology May 2010 (Rutgers University, School of

Environmental & Biological Sciences, New Brunswick, NJ)

Research Experience

Research Assistant, (Rutgers University) September- December 2009

• Assisted Professor in studying the experiments investigating infectious diseases

on horses using aseptic techniques.

• Performed extraction protocols to recover bacterial DNA from gram-positive and

gram-negative bacteria

• Evaluated bacterial extracts in PCR and Real-Time PCR assays and determined

the efficacy of DNA extraction using sigma Plant-N-Extract protocol from pure

cultures of E.coli and L.monocytogenes as well as to evaluate the effect of tissues on

the extraction of bacterial DNA

• Animal Microtechnique, tissue culture and Comparative virology

• Methods in Recombinant DNA technology and Molecular genetics w/d lab

Laboratory Skills

Experience with PCR, Real-Time PCR assays, DNA/RNA extractions

Experience with basic cloning & Aseptic techniques

Experience with ELISA, HPLC, UV, Gel Electrophoresis, Western Blotting

Computer Skills

MS word, MS PowerPoint, Microsoft outlook,

Lotus Notes, ELN, EDC, MODA, LIMS, ARGUS, OC/RDC, Totality, Ariba, ReCAP, ARAVO

Committees/Societies/Professional Affiliations

Phi Theta Kappa Honor Society, 2006-2007

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