Research Nurse

• 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

• To work collaboratively with nursing and physician staff in the applicable hospital departments to maximize patient safety

• Complete and document sponsor related training on Study Protocol and amendments, including Investigator meeting,

• 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

• Determine study specific optimal screening method to facilitate patient recruitment. Re-evaluate and modify as needed

• Approach and with patient approval, screen potentially eligible candidates, reviewing medical history and conduct

• Review and confirm eligibility with the investigator.
• Complete study specific screening procedures, confirm eligibility, enroll/randomize the subject, and complete

• Provide patients with education regarding the disease under study as needed and more specifically regarding trial

• 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

• 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

• Prepare for and accommodate sponsor or regulatory audits by adequately preparing, providing accessibility and support

• 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,

• 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

• Nursing skills including history taking, physical and psychosocial assessment, phlebotomy, IVs, medication

• Training: RN degree or diploma, Clinical Research certification, GCP, inspections and audit, Regulatory requirements,

• Computer database and Microsoft Office: Proficient in word, Power Point and Excel
• Autonomous Critical thinking, interpersonal, written and verbal skills

Hamilton Health Sciences