JEREMIE IDI SHABANI
The Jewish General Hospital
9
years of professional experience
Creative, motivated and resourceful individual with 10 years of professional biomedical knowledge, technical writing, and research experience spanning various fields (pre-clinical & clinical). Leader and team player who will ensure the projects and pipelines are executed properly and successfully, while also striving for ways to optimize and innovate to increase productivity.
Work History
Senior Research Ethics Coordinator (Clinical Research Unit)
2 Years 2 Months- Collaborates with MD/investigators, Clinical Research Manager, research coordinator(s) and the Research Ethics Office for the ethics and regulatory management of multiple clinical research studies.
- Liaise with the Research Ethics Office and the sponsor for monitoring/audits in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, ICH/GCP guidelines and applicable regulations.
- Facilitates completion of start-up regulatory and ethics documentation where required to ensure streamlined start up timelines.
- Responsible for the submission of new clinical research protocols and amendments to the Research Ethics Committee.
- Working in tandem with the pharmaceutical company in the preparation of the inform consent form.
- Reports research protocol waivers, protocol deviations and Serious Adverse Events to the Research Ethics Office.
Research Project Manager (PICU) & Program Manager (Sepsis Canada)
1 Year- Oversight and coordination all studies carried out in the PICU setting (REB application, budget management, regulatory responsibilities in accordance with GCP)
- Monitors and follow progress on projects and deliverables ensuring that the projects and deliverables are on-time;
- Ability to communicate with multiple services and liaise with contracts, pharmacy, central laboratory, etc.
- Assist medical residents with research projects (excellent knowledge of study design) & Supervise Research Assistants.
- Assist to prepare protocols and associated documents for grant submissions
- Assist in the design, implementation, curriculum development, management, and evaluation of Sepsis Canada training program.
- Lean Six Sigma Certification (Yellow Belt)
Quality Management Coordinator/Donor Search Coordinator
1 Year 5 Months- Developed, revised and maintained the Quality Management Plan in conjunction with the Program Medical Director & member of patient safety committee.
- Oversought of all elements of the Clinical Program Quality management activities
- Conducting audits to ensure the Quality Management Plan is operating effectively
- Ensuring compliance with regulatory/accreditation requirements & data analysis
- Compiling, preparing & developing the format and scheduling of annual reports
- Coordinating multidisciplinary quality improvement initiatives within TCT program
- Established and maintained systems to review, modify, and approved all policies and procedures intended to monitor compliance with FACT Standards, federal and provincial health regulations and/or the performance of the Clinical Program.
- Analysed and utilized HLA molecular and serological results to identify matched related and (URDs).
- Liaised with Canadian Blood Services Stem Cells Registry to manage all unrelated stem cell donor (URD) searches, from search initiation through to donor selection and confirmation.
- Maintained process for monitoring related and (URD) status and typing progress on an on-going basis.
- Assisted with preparation of donor activation documents under supervision of the Clinical Program Director or delegate MD.
- Evidence of Quality Improvement Certification by TOH
Research Coordinator/Associate Project Manager
6 Months- Managed REB submissions (ROMEO) & coordinated day-to-day operation of multiple clinical studies (ie: communication with investigators, sponsors, regulatory authorities, & coordinate meetings - Committee, Medical oversight, investigator)
- Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, TMF, logs, etc.) including preparation for internal/external audits, final reconciliation, management of regulatory binders and archival.
- Coordinated study visits & executed all aspects of study visits as necessary (ie: reporting adverse events and safety events, assist in managing financial accounts, administering questionnaires, patient screening & recruitment)
- Entered participant data, maintained record, and conducted data quality assessment activities (ie: SPSS, REDCap, EPIC)
- Evidence of TCPS2/GCP/DIV 5 Certification
Clinical Research Coordinator
8 Months- Established and maintained a database tracking patient visits throughout the trajectory of the patients' care (ie: REDCap, SPSS, GraphPadPrism, R)
- Recruited patients to a central biobank for lung and gastric/esophageal cancers and clinical trials (ie: identify and screen potential subjects, obtained informed consent)
- Assisted with data collection, data analysis, and administration of questionnaires to patients (ie: patient recruitment, study documentation, data entry, etc.)
- Prepared REB documents for submission & communicated with regulatory authorities (ie: Nagan, ROMEO)
Clinical Trial Assistant
2 Months- Plan, schedule, and maintain all documentation of study specific trainings.
- Design study tracking reports and graphs impacting clinical study conduct, QC reports, plans and other correspondence prior to Clinical Operations review.
- Assist in quality control verifications of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- Knowledge of ICH-GCP, GLP; Member of Association of Clinical Research Professionals (ACRP).
- Coordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, drug supplies).
- Familiar with roles of Clinical Research Associates (CRA).
Research & Teaching Assistant
2 Years 3 Months- Examined the molecular consequences of disrupted clock-gene expression in the striatum
- Responsible for characterizing underlying molecular pathways associated with mood disorders & alcohol abuse.
- Employed various pharmacological, molecular & statistical techniques
- Successfully identified 5 robust candidates to be implemented in the drug discovery pipeline to the point of clinical trials
Junior Associate Scientist
1 Year 1 Month- Aided in the generation of a novel cell model with CRISPR-Cas9 to investigate the molecular mechanisms underlying the protein, 14-3-3?, in adipogenesis
- Performed multiple molecular techniques to determine quantitative results
Education
Certificate Program (SOCRA/CCRP certified) - Applied Clinical Research
Master of Science (MSc) - Biology, Behavioral Neuroscience
High distinction
Graduate Diploma - Biotechnology & Genomics
Academic Honors
Bachelor of Science: Double Major - Psychology and Biology, Neuroscience & Co-op Option
Skills
Clinical Compliance
Ethics Consultation
Data entry (Research & Development)
Project management
Decision-making
Time management
Leadership & Communication
Flexible & Independent
Negotiation & Problem solving
MS Office
Timeline
Senior Research Ethics Coordinator (Clinical Research Unit)
The Jewish General Hospital
08.2024 - CurrentRead More
Research Project Manager (PICU) & Program Manager (Sepsis Canada)
McGill University Health Centre
08.2023 - 08.2024Read More
Research Coordinator/Associate Project Manager
Children's Hospital of Eastern Ontario Research Institute (CHEO-RI)
06.2022 - 12.2022Read More
Clinical Research Coordinator
McGill University Health Centre
03.2022 - 11.2022Read More
Quality Management Coordinator/Donor Search Coordinator
The Ottawa Hospital - General Campus
02.2022 - 07.2023Read More
Clinical Trial Assistant
Vantage BioTrials (VBT)
12.2021 - 02.2022Read More
Research & Teaching Assistant
Center of Studies for Behavioral Neuroscience (CSBN)
09.2019 - 12.2021Read More
Junior Associate Scientist
Centre De Recherche Du Centre Hospitalier De L'Universite De Montreal (CRCHUM)
05.2017 - 06.2018Read More
Acadia University
Bachelor of Science: Double Major from Psychology and Biology, Neuroscience & Co-op Option
Read More
Concordia University
Graduate Diploma from Biotechnology & Genomics
Read More
Concordia University
Master of Science (MSc) from Biology, Behavioral Neuroscience
Read More
McMaster University
Certificate Program (SOCRA/CCRP certified) from Applied Clinical Research
Read More
Disclaimer
Signature and Date (DD/MM/YYYY) 19/08/2024 JEREMIE IDI SHABANI 18/08/2024
Personal Information
Title: CLINICAL ASSOCIATE/COORDINATOR, RESEARCH SCIENTIST & MANAGEMENT PROFESSIONAL