SEENA CHACKO
Toronto
Summary
Passionate individual with extensive knowledge, demonstrated skills and experience in Clinical Research, Clinical Microbiology, laboratory operations, specimen management, staff training and inventory management; excelled in roles as Junior Microbiologist to Senior Clinical Research Coordinator. Well-versed in study protocols, standard operating procedures and execution in Clinical trial at site level. Excellent problem-solving abilities with a detail-oriented nature.
Overview
14
14
years of professional experience
Work History
Clinical Research Coordinator/Senior CRC/Clinical Data Reviewer
York Dermatology Clinic & Research Centre
01.2022 - Current
- As a Senior Research Coordinator, responsible for managing and coordinating all assigned aspects of Phase II, Phase III and Phase 1V Dermatology Clinical trials ensuring all trial staff's required training completion, appropriate subject recruitment plans are in place and to ensure Site activation from Site Selection within the requested Time limit.
- Handle multiple clinical trials from study start-up/feasibility to close out/database lock/Archival in accordance with ICH-GCP and other applicable local regulations.
- Maintain the quality and scientific integrity of clinical trials to be inspection ready and actively collaborate with cross functional internal and external partners to ensure timely delivery and clean data is maintained.
- Collaborate with Principal investigators, Sub Investigators, Study Sponsors and multidisciplinary teams through virtual meetings and presentations to facilitate smooth implementation and successful completion of clinical trial.
- As a Data reviewer, monitor and review data collection and data entry for all ongoing Clinical trials bi weekly to ensure data integrity and quality assurance on sponsor provided software data entry portals such as EDC-Medidata, Veeva Vault, Almac, Suvoda, DrugDev, Greenphire, Clario, Y-Prime and Signant health Trialmax.
- Responsible for reporting SAE,AEs, AESIs, and query management for all ongoing trials which are time sensitive.
- Maintain Trial master File with all required documents and review data to ensure 100% compliance and accuracy of all documents not but limited to Study Delegation logs, Site training logs, NOL, SUSARs, ICFs & Protocol versions, IBs, Submissions made to ethics and Ethics approvals.
- As a Senior CRC, responsible for training other Research Coordinators, Research Assistants, Phlebotomists on GCP, GDP,SOPs, proper trial execution based on protocol and regulatory requirements.
- Perform the role of an in house CRA by working along with study CRA to execute Site qulaification visits, Site initiation visits, routine monitoring visits to ensure study compliance, no protocol deviations/findings to ensure site is ready for internal audit.
Medical Laboratory Technician
LIFE LABS
07.2021 - 01.2022
- Prepare and sort incoming specimens for technical
- Analysis
- Perform Phlebotomy, ECG and Holter
- Perform special test collection such as Medical/Legal
- Dug screen, PANORAMA and related documentation
- Conduct all work in compliance with Laboratory safety and regulations.
Senior Laboratory Research Technician
Maple Leaf Research
01.2020 - 12.2021
- Implement Lab procedures to ensure data integrity and data quality control increasing accuracy in documentation, continuous improvement of research procedures and quality sample collection for 98-100% accuracy
- Train and guide Research and Laboratory assistant staff on LAB SOPs, study laboratory manuals and Good
- Laboratory Practices to ensure a quality driven environment
- Excellent planning and coordination of specimen management, which include sample collection, processing, and shipping based on Laboratory SOPs and study protocol, with 100% accuracy
- Accountable for inventory management for all laboratory supplies, and calibration of all laboratory equipment and freezers.
Medical Laboratory Technician
Alpha Laboratories
08.2015 - 07.2019
- Exceeded expectations with processing techniques for cultures, microscopy, and staining
- Assisted Senior technologists with Antibiotic sensitivity testing, Media preparation, sterilization, and QC checking for media to ensure 0% chance for contamination.
- Plating and identification of microbiology samples.
- Perform data entry and inventory management in a timely manner.
Microbiologist
Medinova Diagnostics
08.2010 - 03.2014
- India
- Responsible for microbiology laboratory operations including reading of culture plates, susceptibility testing and communicating reports to Physician in charge
- Maintained QA policies and procedures to ensure validity of test results with 100%accuracy
- Provided hands on training to a team in staining, isolation techniques, handling of laboratory equipment and sterilization procedures fostering superior in Good
- Laboratory Practices.
Education
CERTIFICATION - CLINICAL SITE COORDINATOR /MANAGER & GCP WORKSHOP
SOCRA
07.2021
Post Graduate Diploma - QA &QC
Toronto Institute of Pharmaceutical Science
Toronto02.2017
Diploma - Medical Laboratory Technician
CJ Health Care Collage
Toronto 06.2015
Master of Science - Medical Microbiology
Kannur University Campus
Kannur, INDIA03.2010
Skills
- Laboratory operations
- Phlebotomy/ECG
- Microbiology plating and microscopy
- Employee training
- Shift scheduling
- Specimen management
- Inventory management
- Research methods
- QA&QC, CAPA,
- Change control, SOPS
- Soft ware platforms LDMS, Med Access,OSCAR, EDC,Veeva Vault, Almac, Suvoda and Y-prime
- Certifications
- Clinical Trial Site Coordinator /manager & GCP certification
- OSMT
- CITI IATA/TDG
- CITI ICH GCP
- NIH GLP
- NIH GCP
- Health Canada Part C, Division-5 Drugs for Clinical Trials involvingHumans
Languages
English
Tamil
Hindi
Timeline
Clinical Research Coordinator/Senior CRC/Clinical Data Reviewer
York Dermatology Clinic & Research Centre
01.2022 - Current
Medical Laboratory Technician
LIFE LABS
07.2021 - 01.2022
Senior Laboratory Research Technician
Maple Leaf Research
01.2020 - 12.2021
Medical Laboratory Technician
Alpha Laboratories
08.2015 - 07.2019
Microbiologist
Medinova Diagnostics
08.2010 - 03.2014
CERTIFICATION - CLINICAL SITE COORDINATOR /MANAGER & GCP WORKSHOP
SOCRA
Post Graduate Diploma - QA &QC
Toronto Institute of Pharmaceutical Science
Diploma - Medical Laboratory Technician
CJ Health Care Collage
Master of Science - Medical Microbiology
Kannur University Campus
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