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Research Nurse

Hamilton Health Sciences

This is a Contract position in Hamilton, ON posted January 17, 2023.

• Implement clinical trial protocols according to ICH GCP guidelines from regulatory submission to study close-out.
• Identify potential clinical trial candidates, screen, randomize, coordinate and conduct follow-up visits according to study protocol ensuring subject safety (appropriate escalation and oversight by PI), timelines and protocol requirements are met.  
• Provide and document training for applicable hospital staff/departments on Protocol requirements and provide ongoing training for amendments and new staff.
• Determine study specific optimal screening method to facilitate patient recruitment. Re-evaluate and modify as needed to maximize enrollment and meet numbers and timelines for recruitment
• Approach and with patient approval, screen potentially eligible candidates, reviewing medical history and conduct interview and physical exam where needed to ensure eligibility criteria are satisfied.  Explain the study in detail and obtain written informed consent following GCP guidelines and documenting consent process.
• Review and confirm eligibility with the investigator.
• Complete study specific screening procedures, confirm eligibility, enroll/randomize the subject, and complete randomization visit requirements.
• Provide patients with education regarding the disease under study as needed and more specifically regarding trial related activities and requirements.
• Devise tool to maximize patient retention and minimize lost to follow-up.
• Conduct virtual care clinical visits with patients enrolled in the intervention group of the trial, working collaboratively with physician staff in the virtual clinic to maximize patient safety and protocol adherence.
• Screen the virtual care platform for alerts and out of range values that require action
• Complete and document data entry, including patient-reported measures and other pertinent data
• Assess adherence to protocol, ensure completion of all follow-up activities including questionnaires, sample collection, diagnostic measurements.
• Review lab results for any clinically significant findings and escalate/report as required.
• Assess for and report any AEs, SAEs or endpoints identified at the follow-up visits or anytime.
• Complete required close-out activities and ensure subject support at study conclusion.
• Collect and document on source details required at each patient visit.
• Follow GCP guidelines for collection, correction and Investigator review.
• Ensure Investigator review and sign off of study related documents completed within required timeframe.
• Enter data into CRF and respond to queries within required timeframe.
• Follow expedited reporting guidelines to report SAEs and applicable endpoints to sponsor, IRB, and regulatory authorities.    
• Prepare for and accommodate sponsor or regulatory audits by adequately preparing, providing accessibility and support during the audit, participating in exit meeting, responding to observations
• Prepare all documents required for REB amendments and ongoing communication with REB for amendment notifications, protocol deviations, SAE reporting, annual renewals, study close out. 
• Obtain and provide ongoing updates to history and physical exam
• Obtain lab samples and required study medical tests.
• Administer medications.
• Administer and read study tests
• Provide patient education and support regarding disease under study, medications and health education

Package

Salary: 37-47.44