Research Nurse

Hamilton Health Sciences•Hamilton, ON

About The Position

The Research Nurse will implement clinical trial protocols according to ICH GCP guidelines from regulatory submission to study close-out. This role involves identifying potential clinical trial candidates, screening, randomizing, coordinating, and conducting follow-up visits according to study protocols, ensuring subject safety, timelines, and protocol requirements are met. The nurse will collaborate with nursing and physician staff to maximize patient safety and protocol adherence, complete sponsor-related training, and provide training for hospital staff. Key responsibilities include determining optimal screening methods for patient recruitment, approaching and screening eligible candidates, obtaining informed consent, confirming eligibility with the investigator, administering study medications, assessing compliance, collecting samples, reporting adverse events, and completing close-out activities. The role also involves data entry, responding to queries, reporting SAEs, preparing for audits, and managing regulatory documentation.

Requirements

Nursing skills including history taking, physical and psychosocial assessment, phlebotomy, IVs, medication administration, sterile technique, health teaching.
RN degree or diploma
Clinical Research certification
GCP training
Training in inspections and audit
Knowledge of Regulatory requirements
Knowledge of SAE reporting
Knowledge of Therapeutic area
Proficient in computer database and Microsoft Office: word, Power Point and Excel
Autonomous Critical thinking, interpersonal, written and verbal skills

Nice To Haves

Experience running randomized controlled trials and other prospective studies a significant asset

Responsibilities

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, timelines and protocol requirements are met.
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.