Rabiya Atif
Carlingford
Summary
Highly skilled professional with extensive experience in clinical trials, contract negotiations, feasibility assessments, laboratory techniques, and administrative operations. Adept at managing complex research protocols, ensuring regulatory compliance, and optimizing efficiency in clinical and laboratory environments. Proven ability to negotiate and execute contracts, streamline feasibility processes, and support critical administrative functions. A detail-oriented and analytical approach combined with strong communication and organizational skills to drive success in research and healthcare settings.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Study Start Up Associate II
Harvest Integrated Research Organization (HiRO)- previously known as Pharmaceutical Solutions Pty Ltd
05.2023 - Current
- Writing and QC of country-specific and site-specific PIS-ICF
- Preparation of initial Institutional Review Board/Independent Ethics Committee (IRB/IEC) submission
- Preparation of initial Regulatory Authority (RA) submission
- Collection and QC of Essential Document (ED) Package
- May attend client meeting to provide status update for IRB/IEC submission, RA submission, Trial Site budget negotiation, Trial Site contract and indemnity execution, ED package collection.
- Support Project Manager in:
- Writing and QC of country-specific and site-specific PIS-CF amendments
- Preparation of IRB/IEC amendments
- Preparation of RA amendments
- Support Site Contract Specialist in:
- Clinical trial budget negotiation with Trial Sites
- Generation and QC of Trial Site contract, Trials Site contract amendments and Trial Site indemnity agreements.
- Facilitating execution of Trial Site contract, Trial Site contract amendment and Trial Site indemnity agreements
- Updating tracking systems related to Trial Site budget negotiation, Trial Site contract and indemnity execution.
- Support Feasibility Lead in
- Conduct clinical trial do-ability and feasibility assessment outcome
- May attend client meeting to communicate feasibility assessment outcome
- Carried out other assigned administrative duties and departmental tasks to support clinical trial conduct or department
- Complete duties according to ICH-GCP and local regulatory requirements and legislation
- Develop training material and conduct training of PharmaSols/HiRO staff.
- Contributing in updating policies and SOPs.
Country Approval Specialist
PPD, Part of Thermo Fisher Scientific
11.2021 - 04.2023
- For preparing, submitting and following up on initial study and follow-up submissions to the Regulatory Agency, IRB/IEC, and any other submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval.
- For preparing, submitting and following up on subsequent study amendments and follow-up submissions to the Regulatory Agency, IRB/IEC, and any other submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval.
- For working with Site Contract Team to ensure site budget and contract start negotiation simultaneously with submission and partially- executed contract will be at site prior to ethics approval being granted.
- For application of all importation and exportation requirements are met for IP and any other clinical trial supplies (lab kits, medical devices etc.) needed for the trial within their country.
- For reviewing and verifying the translation into the local language of document that is required for submission and clinical trial supply labelling to ensure it meets local regulatory requirements and to ensure that Insurance Certificates, Country-Specific Informed Consent Forms (ICFs), and any other subject documentation adhere to country requirements.
- For essential documents collection to ensure the IP Release Package Readiness is achieved as quickly as possible to release IP to the site prior to SIV.
- For uploading CAS related documents into Project Point and eTMF as per study timeline. For any other additional tasks that might be assigned by the line manager (LM).
In House CRA III/ Clinical Trial Coordinator
PRA Health Sciences
10.2019 - 11.2021
Maternity
11.2018 - 09.2019
Start-up Specialist and Regulatory I
Syneos Health- InVentiv Health
05.2018 - 11.2018
In House CRA 1/ Clinical Trial Coordinator
PRA Health Sciences
01.2017 - 05.2018
Clinical Trial Coordinator
Sydney West Retina Pty Ltd, Westmead
07.2016 - 01.2017
Research Assistant
Woolcock Institute and Medical Research
10.2015 - 07.2016
Microbiology Technical Assistant
PaLms, Royal North Shore Hospital, St Leonards
08.2013 - 10.2015
Clinical Trials and pharmacy Assistant
The Crown Princess Mary Cancer Centre (Westmead Millennium Institute for Medical Research), Westmead Hospital
05.2014 - 08.2014
Microbiology Technical assistant
Healthscope Pathology, Bella vista
01.2012 - 01.2013
Administration Officer
Jesmond Nursing Home
01.2008 - 01.2012
Education
Master of Public Health -
Griffith University
Brisbane, QLD12.2021
Bachelor of Science - Pharmacology
University of Sydney
Sydney, NSW12.2015
Diploma - Science and Engineering
INSEARCH: UTS
Sydney, NSW08.2008
High School Diploma -
St Bridget’s Convent
Colombo, Sri Lanka09.2007
Skills
- Collaborative teamwork
- Customer engagement
- Adaptable to changing environments
- Strategic issue resolution
- Meticulous attention to detail
- Prioritization and scheduling
- Strong ability to prioritize tasks simultaneously
- Strong planning and prioritization abilities
Certification
- The University of Queensland edX May 2020
- Understanding the Australian Health Care System
Timeline
Study Start Up Associate II
Harvest Integrated Research Organization (HiRO)- previously known as Pharmaceutical Solutions Pty Ltd
05.2023 - Current
Country Approval Specialist
PPD, Part of Thermo Fisher Scientific
11.2021 - 04.2023
In House CRA III/ Clinical Trial Coordinator
PRA Health Sciences
10.2019 - 11.2021
Maternity
11.2018 - 09.2019
Start-up Specialist and Regulatory I
Syneos Health- InVentiv Health
05.2018 - 11.2018
In House CRA 1/ Clinical Trial Coordinator
PRA Health Sciences
01.2017 - 05.2018
Clinical Trial Coordinator
Sydney West Retina Pty Ltd, Westmead
07.2016 - 01.2017
Research Assistant
Woolcock Institute and Medical Research
10.2015 - 07.2016
Clinical Trials and pharmacy Assistant
The Crown Princess Mary Cancer Centre (Westmead Millennium Institute for Medical Research), Westmead Hospital
05.2014 - 08.2014
Microbiology Technical Assistant
PaLms, Royal North Shore Hospital, St Leonards
08.2013 - 10.2015
Microbiology Technical assistant
Healthscope Pathology, Bella vista
01.2012 - 01.2013
Administration Officer
Jesmond Nursing Home
01.2008 - 01.2012
Master of Public Health -
Griffith University
Bachelor of Science - Pharmacology
University of Sydney
Diploma - Science and Engineering
INSEARCH: UTS
High School Diploma -
St Bridget’s Convent
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