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Clinical research coordinator Jobs in Burlington, ON
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Hamilton Health SciencesHamilton, Ontario- Part-time
Unit Summary
The division of neurology strives to take part in a diverse array of clinical research, including clinical trials and observational studies. This observational study aims to assess the function and quality of life of patients with Parkinson's disease with and without communication with a nurse.
This is a hybrid remote / in-person temporary part-time position whereby the successful candidate will be actively involved in a feasibility-controlled trial to investigate the addition of an Integrated Care Network to usual physician-centered care to address complex care needs in Parkinson disease.
Position Summary
- Implement study protocols according to ICH GCP guidelines from regulatory submission to study close-out.
- Identify potential study 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
- Administer and read study tests
- Provide patient education and support regarding disease under study, medications and health education
Schedule Work Hours
Temporary part-time hours (22.5 hours / week). The position is temporary for one year.
Qualifications
Assets :
Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.
To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website.
Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact HR Services at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made. This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note : the circumstances around an employee's exit will be considered prior to an offer of employment
Proficiency in both Official Languages, French and English, is considered an asset