Clinical Research Assistant

2 weeks ago

Hamilton, Canada LEADER research Full time

LEADER research, located in Hamilton, ON, is a clinical research site focused on the area of Clinical Trials in Clinical Immunology and Dermatology. Our team conducts and coordinates Phase II-IV clinical trials in a space created for the benefit of patients who require advanced treatments.

LEADER research stands for Lima’s Excellence in Allergy and Dermatology Research. Its name shows an ongoing pursuit of excellence in knowledge and improvement, embracing the state of intellectual curiosity, leadership, and innovation. Therefore, excellence means attaining a world-class quality level in allergy and dermatology clinical research.

Currently, we are excited to bring on a **Clinical Research Assistant** who can work with us in this **FULL-TIME **temporary position for 1 year with the possibility of becoming a permanent position. This position may have opportunities for growth and development.

A position at this level has a primary purpose of performing a range of routine research duties supporting the clinical research team in their daily activities and will report to the Principal Investigator. However, tasks and instructions may be handed out from Clinical Research Coordinators within the unit.

Through our affiliation with Probity Medical Research (PMR), the LEADER research staff has access to training in ICH-GCP, Health Canada Division 5, and Transportation of Dangerous Goods.

LEADER research staff may have access to **group benefits** as Dental and Extend Health care, Long-Term Disability, Critical Illness, Accidental Death, and Dismemberment, some of them are also available for the employee's spouse and children.

**Qualifications**:

- A Bachelor’s degree or Diploma in the field of Science or Health Science is preferred.
- Strong communication and interpersonal skills (written and oral) with a good command of the English language.
- Highly detail-oriented with exceptional organizational skills.
- Ability to take initiative and work independently in a fast-paced environment.
- Proficiency with MS Office (Word, Excel, Outlook).
- Knowledge of medical terminology, familiarity with pharmaceutical medications, general research procedures, and regulatory requirements are assets.
- Knowledge of Electronic Medical Records (EMR)/Accuro and Electronic Data Capture systems are assets.
- Experience in allergy/immunology or dermatology fields is an asset.

**Responsibilities**:

- Help with administrative tasks to ensure each study material is highly organized.
- Photocopy, fax, maintain study binders, create source documentation, and replenish participants' folders for each study.
- Work together with the finance department to ensure that participants are reimbursed on time and in accordance with the protocol.
- Maintain, organize, and order laboratory supplies, including dry ice, rescue therapies, and background study medications.
- Maintain and organize examination rooms, offices, and labs.
- Receipt, storage, and accountability maintenance of study medication, including monitoring of temperature thermometers, and creating temperature deviation reports, if applicable.
- Handle couriers’ services, booking, rescheduling, canceling, preparing lab specimens for shipment, and with local or central laboratories queries or issues.
- Perform procedures such as venipuncture, pipetting, handling biological samples, administering medication by injection or other routes, and vital signs measurement.
- Regularly confirm the receipt and print lab/ECG/Tests reports and send them to investigators for signature.
- Participate in the informed consent process by providing a description of the background, purpose, and schema of the study.
- Mediate with participants, family members, and caregivers of study participants supporting understanding of the procedures, potential risks, and possible benefits inherent to their involvement in the study.
- Perform collection, interpretation, and recording of data in accordance with sponsor guidelines and standards.
- Collect, verify, evaluate, and record participants' study data in databases or Case Report Forms (paper or electronic) and solve queries as necessary, in a timely and accurate manner.
- Keep study participants informed of study progress through regular reports and newsletters.
- Train on SOPs, ICH-GCP, HC Division 5, TDG, CPR, PMR, and all required training sessions on sponsor databases, online portals, and or study-specific systems as required to conduct each protocol.
- Handle with studies supplies deliveries: receive, check, store, return, contact provider if applicable, etc.
- Monitor phone, fax, and mail frequently; monitor and order office supplies.
- Update and maintain information in a variety of databases, spreadsheets, general documents, and SharePoint.
- Develop and implement SOPs for clinical research.
- Chair research group meetings.
- Participate in sponsor monitoring visits and conference calls.
- Ensure that the relevant research methodology is applied, a

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