Research Nurse - #110698

Hamilton Health Sciences


Date: 3 weeks ago
City: Hamilton, ON
Contract type: Full time

• 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.
• To work collaboratively with nursing and physician staff in the applicable hospital departments to maximize patient safety
and protocol adherence.
• Complete and document sponsor related training on Study Protocol and amendments, including Investigator meeting,
data entry, GCP, Endpoint, AE and SAE reporting, Investigational Product.
• Ensure delegated staff have also completed appropriate training prior to subject enrollment.
• 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.
• Administer/dispense/retrieve study medication, assess compliance, 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 REB application for clinical trial according to REB specifications.
• Prepare all documents required for submission to REB including informed consents, recruitment materials, budget etc.
• Ongoing communication with REB for amendment notifications, protocol deviations, SAE reporting, annual renewals,
study close out.
• Oversee maintenance of regulatory documentation
• Obtain and provide ongoing updates to history and physical exam
• Obtain lab samples and required study medical tests.
• Administer study oral or IV medications.
• Administer and read study tests
• Provide patient education and support regarding disease under study, medications and health education

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