Type de poste : Permanent Ville : Montréal
Expérience requise : 2 ans
Statut : Temps plein
Description du poste
The incumbent in this role is responsible for monitoring the progress of clinical studies at clinical sites or remotely, and ensure clinical studies are conducted, recorded, and reported in accordance with the protocol, monitoring plan, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and other applicable regulatory requirements.
Job Interactions and Interface:
This position interacts with site investigators, study coordinators, pharmacists and all other clinical personnel, Project Managers, and sponsors.
- Monitor clinical studies at clinical sites or remotely for compliance with the protocol, monitoring plan, SOPs, GCP and other applicable regulatory requirements and in accordance with the study timelines
- Ensure the rights and well-being of clinical study subjects are protected
- Perform pre-study, site initiation, monitoring and close-out activities
- Review clinical data, source documentation, case report form and clinical site regulatory files for accuracy, completeness and compliance
- Prepare and submit to the MHICC Project Manager, clinical monitoring reports and follow-up letters as per required timelines; review and follow-up on site corrective actions until resolution
- Manage assigned clinical sites to ensure site compliance, adequate enrollment, and according to study requirements
- Serve as a resource and main point of contact for study coordinators, site investigators, and other study site staff
- Participate in MHICC and sponsor training
- Provide training and inform clinical sites of any changes in study conduct and documentation requirements
- Communicate with the clinical site, sponsor and MHICC Project Manager, and ensure critical observations are immediately communicated and effective resolution is obtained
- Work closely with data management and the clinical site to resolve discrepancies
- Ensure appropriate reporting and follow-up for all safety information by the study site staff
- Proactively identify issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues
- Ensure audit or regulatory inspection readiness at assigned clinical sites and assist the site’s preparation for an audit and/or regulatory inspection
- Perform necessary administrative functions (e.g. planning and scheduling of work, tracking of time on clinical studies, maintaining and completing expense reports, etc.)
Education: Bachelor’s degree in health sciences or nursing.
Experience: A minimum of two (2) years clinical research monitoring and/or clinical study coordination.
Skills: Excellent organizational, time management and problem solving skills. The ability to work with study teams and with supervision. Excellent interpersonal and communication skills and detailed oriented. Must have French and English verbal and written communication abilities.
Knowledge: Good knowledge of clinical studies monitoring, GCP and other applicable regulatory requirements, and clinical research methodology. Computer literacy, proficiency in MS Office.
Conditions de travail
- Incumbent may be required to work overtime if required
- May require some travel, approximately 25-40% of time
TO SUBMIT YOUR APPLICATION
- Final date to apply : July 9th, 2021
- By email : [email protected]
- Your presentation letter and your resume must be combined in one file (Word or PDF) and it must be identified this way : Name_Last name (ex : Hamel_Danny)
- Please indicate the job title for which you’re submitting your application
We offer equal employment opportunities to all.
Only candidates that have been met will receive a written answer
This job description is not created to imply that these requirements are the only duties, responsibilities and qualifications for the job. Incumbents may be required to follow any additional related instructions, acquire related job skills and perform other related work, as required.