Julie Demers-Lamarche
Trois-Rivières
Summary
Dynamic Clinical Research Associate II with proven expertise at IQVIA in site management and effective communication. Skilled in enhancing data quality and ensuring regulatory compliance, I excel in training teams and improving study recruitment strategies. Recognized for implementing innovative processes that boost operational efficiency and support successful clinical trials.
Clinical research professional with track record of managing and monitoring clinical trials effectively. Expertise in regulatory compliance and protocol adherence, ensuring integrity of data and participant safety. Known for collaborative team efforts and adaptability to evolving project needs, bringing strong organizational and analytical skills to table.
Overview
12
12
years of professional experience
Work History
Clinical Research Associate II
IQVIA
02.2021 - Current
- Supports the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded, and reported in accordance with the protocol, GCP, SOPs and regulations.
- Participates in the study startup activities and site opening activities as well as study conduct and site closure tasks.
- Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas. Ensures quality of data submitted from study sites and assures timely submission of data.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-3 studies.
- Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.
- Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written report.
- Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs.
Research Study Coordinator
CIC Mauricie
03.2018 - 04.2020
- Manage and improve all studies recruitment by developing and implementing effective communication strategies.
- Prepare and maintains site SOPs and source document templates in compliance GCP and applicable regulations.
- Assist patients visits scheduling and procedures.
- Managed laboratory operations and samples, ensuring proper handling and storage.
Lab Manager
UQTR - Cellular and Molecular Biology Lab
09.2013 - 04.2018
- Implemented automated processes and equipment upgrades, enhancing lab efficiency.
- Established and negotiated lab budget while ensuring fiscal compliance.
- Managed inventory of reagents and lab equipments to maintain operational readiness.
- Oversaw training and support for undergraduate student team, fostering skill development.
Education
Bachelor of Science - Biology And Environment
Universite Du Quebec A Rimouski
RimouskiPh.D. - Cellular And Molecular Biology
Universite Du Quebec A Trois-rivieres
Trois-Rivières, QC04-2018
Master of Science - Neuromusculodegenerative Diseases
Universite De Montreal
Montreal, QC01-2011
Skills
- Site management
- Effective communication
- Good clinical practice
- Canadian clinical regulations
- Detailed documentation
- Team leadership
- Study management
- Complex problem solving
Languages
French
Native or Bilingual
English
Native or Bilingual
Timeline
Clinical Research Associate II
IQVIA
02.2021 - Current
Research Study Coordinator
CIC Mauricie
03.2018 - 04.2020
Lab Manager
UQTR - Cellular and Molecular Biology Lab
09.2013 - 04.2018
Bachelor of Science - Biology And Environment
Universite Du Quebec A Rimouski
Ph.D. - Cellular And Molecular Biology
Universite Du Quebec A Trois-rivieres
Master of Science - Neuromusculodegenerative Diseases
Universite De Montreal
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