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Brunel: Clinical Research Associate

Brunel

This is a Full-time position in Montreal, QC posted September 17, 2020.

Clinical Research Associate Montreal, QC Introduction We’re hiring a Clinical Research Associate for a biopharmaceutical company for a 1-year contract in Montreal, QC.

Responsibilities Under the supervision of the Clinical Operations Manager or the Project Manager, Clinical Research, the Clinical Research Associate’s primary responsibilities will be: Every day Manage investigator sites: participating in Phase I to IV and PMOS clinical studies.

Organize and manage critical documents / clinical trial master file.

Identify critical issues and bring them to the attention of team members including local management, Project Managers, and members of the Global Project Team.

Coordinate day-to-day project-related activities of contract monitors, CROs, central labs and other service providers as required.

Every week Plan and coordinate study supplies (drug, laboratory, etc.).

Acquire knowledge in and work according to SOPs, GCP, relevant regulatory guidance and local law.

Routine clinical monitoring of clinical sites for compliance with GCP, the study protocol, reporting of adverse events, accounting for study drug, verification of study CRF data against source documents, and completion and filing of regulatory documents.

Review trip reports (monitoring visit reports) completed by contract monitors or other team members.

Every month Assist in preparing study budgets and ensures payments.

Ensure management is kept informed of study progress through trip reports and enrollment updates.

Assist with and track the resolution of queries generated by data management.

Assist in drafting study protocols and designing CRFs, patient diaries, medication labels or other study materials when required.

Every year Assist in Site Selection and Site Evaluation when required.

Initiate and train study sites.

Assist in the organization and conduct of investigator meetings.

Close-out of study sites.

Assist with audits and audit reports.

Requirements 1 to 3 years of experience in a similar position.

Bachelor degree related to Life Sciences Experienced in all aspects of study monitoring (data monitoring, drug accountability, regulatory documents, etc.) Proficiency in GCP and ICH/HPB guidelines Ability to assimilate product and protocol knowledge quickly Attention to detail/deadlines Good organization skills Good communication (written / oral) Self-motivator Flexible Good interpersonal skills Availability for travel (This position entails 5% of travel within Canada and very limited travel outside Canada (valid passport is required).

Language and computer skills Intermediate knowledge of French (written and verbal) Advanced knowledge of English (written and verbal).

Intermediate knowledge of Word, PowerPoint, Outlook, Excel and of eDC systems.