Clinical Research Coordinator/supervisor

3 weeks ago

Hamilton, Canada Winterberry Family Medicine Full time

**Job Summary**

We are looking for a smart, hard-working individual who wants to make a difference. Our research work brings new treatment options to Hamilton-area patients and shapes the future of how medicine will be practiced. Are you up for the challenge?

**Required Education and Experience**

Interested applicants should have an undergraduate degree in the health sciences or a college diploma in nursing. A minimum of 3 years of research coordinator experience, SoCRA, ACRP certification, and/or training in ICH GCP guidelines are assets. Excellent written and verbal communication skills, a proficiency in MS Office, and strong time management and organizational abilities are critical. Supervisory or managerial experience is an asset.

**Responsibilities**

In this role you must be able to work independently in a changing, fast-paced environment and manage multiple studies in different therapeutic areas. To accommodate patients’ availability, weekday evenings and weekend hours may be required.
- Understand, manage and comply with multiple research protocols
- Assist in the assessment of eligibility of study participants
- Administer and document informed consent of research participants
- Attend Investigator meetings (may require weekend travel)
- Coordinate and participate in monitoring visits with Study Sponsors or their designates (CROs); work with the PI, as applicable, to promptly resolve any issues identified by the monitor during such visits.
- Participate in inspections by regulatory authorities (Health Canada, FDA) or audits by Study Sponsors
- Design and manage a system for organizing and controlling workflow related to patient visits and clinical research activities for each study
- Perform study assessments as per CRC qualifications and documented delegation
- Collect research data and document adherence to the protocol in accordance with good clinical practice (GCP), good documentation practices, and regulatory requirements
- Ensure adverse events are identified and properly documented and the PI alerted of their occurrence; ensure serious adverse events are reported to the sponsor and ethics committees in a time sensitive manner
- Assist in the preparation of Ethics Committee submissions, and annual progress reports and other research-related reports to the Ethics Committee (e.g., protocol deviations, SAEs)
- Assist in the preparation of documentation required by the regulatory authorities (e.g., Health Canada, FDA)
- Organize and file documentation in investigator study files so that documentation is always audit ready
- Perform data entry into the eCRF within required timelines after each study visit, and respond promptly to data queries
- Collect biological samples, prepare laboratory requisitions and shipment documents, and package samples for transport
- Use good clinical judgment to report study problems to Principal Investigator, sponsor and ethics committee as appropriate (e.g., major protocol deviations, GCP concerns)
- Actively participate in training required for study personnel (e.g., GCP, protocol training and training on amendments, study systems)
- Maintain training documentation and personnel records such as CVs and licenses
- Document the maintenance/calibration of equipment used in the conduct of clinical research
- Update Trial Management Group Inc. on the progress of studies
- Follow Standard Operating Procedures and regulatory requirements

**Job Types**: Full-time, Permanent

**Salary**: $65,000.00-$75,000.00 per year

**Benefits**:

- Company events
- Dental care
- Disability insurance
- Life insurance
- On-site parking
- Vision care

Schedule:

- 8 hour shift

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