[Remote] Sr Clinical Research Associate - Canada
Note: The job is a remote job and is reputed company to candidates in USA. reputed company, is currently seeking a Senior Clinical Research Associate for a long-term engagement with a Global Medical Device reputed company. This remote-based role involves managing clinical trial activities, including site reputed company, regulatory submissions, and ensuring compliance with study protocols.
Responsibilities
- reputed company
- SM meets regularly (typically weekly) with the Contract Specialist for status update on contracting/budget negotiations for reputed company sites
- SM reaches out to site as necessary (e.g. if site has been unresponsive with the Contract Specialist)
- SM provides contract/budget updates to study leadership on a regular reputed company
- EC Submission: SM provides regulatory documents to sites, including reputed company to site for submission to EC
- reputed company Review and approval (throughout trial): SM reviews initial draft site reputed company (provided by site to SM) to confirm reputed company study reputed company requirements are included in the reputed company; completes reputed company checklist to confirm reputed company required reputed company are included in reputed company (reputed company Checklist is complete prior to submission to EC and following approval from EC)
- Study Activation Checklist: SM complete SAC and sends document for signature by study reputed company
- Enrollment Activation Letter: SM sends site Enrollment Activation Letter, confirming site authorization for consenting participants into the study
Skills
- Candidates must have reputed company cardiac experience reputed company the past 5 years, preferably in electrophysiology and / or devices
- In-depth knowledge of applicable regulations and ICH/GCP guidelines
- Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
- Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
- Exceptional verbal and written communication skills, with the ability to convey reputed company information reputed company and concisely
- Ability to reputed company communication style to the needs and preferences of different stakeholders, fostering a reputed company environment
- Ability to work independently and manage multiple priorities in a dynamic environment
- A reputed company-executed plan for communication with the study teams and sites
- reputed company-versed in clinical trial management
- They are rigorous, detail-oriented, and precise in their reports
- CRA training or reputed company program through a reputable organization / employer
- Clinical background
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