Clinical Research Associate
1 week ago
The Site Monitor I will be responsible for ensuring data integrity, data quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on-site visit requirements.
Key Responsibilities:- Ensure regulatory, ICH-GCP, and protocol compliance, using judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject as required.
- Demonstrate diligence in protecting the confidentiality of each subject and assess factors that might affect subject safety and clinical data integrity at an investigator site.
- Conduct source document review and verification of appropriate site source documents and medical records.
- Manage reporting of protocol deviations and appropriate follow-up.
- Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- May perform Investigational Product (IP) inventory, reconciliation, and reviews storage and security.
- Verify the IP has been dispensed and administered to subjects according to the protocol and verify issues or risks associated with blinded or randomized information related to IP.
- Apply knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned.
- Document activities via follow-up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
- Ensure all activities are managed by site personnel who are appropriately delegated and trained.
- Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
- A minimum of 1 year experience as a clinical monitor/clinical research associate with demonstrated experience of on-site monitoring.
- Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) or can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice.
- Proficiency in local language is required.
- English proficiency is required.
- Ability to manage required travel of up to 75% on a regular basis.
Parexel is a leading global biopharmaceutical services company, and we offer a dynamic and challenging work environment. We are committed to helping our clients succeed in their clinical trials, and we are looking for talented individuals to join our team.
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Québec, Quebec, Canada Syneos Health Full timeJob Title: Clinical Research Associate IIAt Syneos Health, we are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for managing clinical trials and ensuring compliance with regulatory requirements.Key Responsibilities:Conduct site initiation visits and monitor clinical...
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Québec, Quebec, Canada Parexel Full timeJob Summary:The Site Monitor I will be responsible for ensuring data integrity, data quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. This role will involve monitoring activities in line with the Study Monitoring Plan (SMP) and collaborating with the Site...
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Québec, Quebec, Canada Parexel Full timeJob Summary:The Site Monitor I will be responsible for ensuring data integrity, data quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. This role will involve monitoring activities in line with the Study Monitoring Plan (SMP) and collaborating with the Site...
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Clinical Research Associate II
2 weeks ago
Québec, Quebec, Canada Syneos Health Full timeJob Title: Clinical Research Associate IIAt Syneos Health, we are passionate about developing our people and creating a Total Self culture where everyone feels like they belong. We are seeking a Clinical Research Associate II to join our team.Job Summary:The Clinical Research Associate II will be responsible for performing site qualification, site...
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Québec, Quebec, Canada Syneos Health Full timeAbout the RoleWe are seeking a highly skilled Clinical Research Associate II to join our team at Syneos Health. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.Key...
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Québec, Quebec, Canada Parexel Full timeJob Summary:The Site Monitor I will be responsible for ensuring data integrity, data quality, and compliance with International Council for Harmonization and Good Clinical Practice (ICH GCP) and local requirements at the site level. This role will involve monitoring activities in line with the Study Monitoring Plan (SMP) and collaborating with the Site...
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1 week ago
Québec, Quebec, Canada Syneos Health Full timeAbout Syneos HealthAs a leading fully integrated biopharmaceutical solutions organization, Syneos Health is built to accelerate customer success. Our team of experts translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job SummaryWe are seeking a highly skilled Clinical Research Associate I to...
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Clinical Research Associate I
1 week ago
Québec, Quebec, Canada Syneos Health Full timeAbout Syneos HealthAs a leading fully integrated biopharmaceutical solutions organization, Syneos Health is built to accelerate customer success. Our team of experts translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job SummaryWe are seeking a highly skilled Clinical Research Associate I to...
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Clinical Research Associate II
2 days ago
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