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Clinical Research Assistant

2 weeks ago

North York, Canada North York Research Inc. Full time

North York Research Inc. is the Clinical Research Division of North York Dermatology Clinic. We conduct clinical trials in multiple skin conditions such as atopic dermatitis, psoriasis, vitiligo and hidradenitis suppurativia for various pharmaceutical sponsors.

The Clinical Research Assistant supports the daily conduct of industry-sponsored clinical trials at the site. This is an operational, patient-facing role working under the direction of Clinical Research Coordinators (CRCs) and Qualified Investigators (QIs).

Key Responsibilities
- Maintain the Investigator Site File (ISF) and regulatory documentation.
- Prepare source documents, visit materials, and support informed consent as delegated.
- Schedule and follow up with trial participants; manage reminders and communications.
- Assist with eligibility reviews, chart checks, intake calls, and recruitment activities.
- Collect study data during visits, administer questionnaires, and record outcomes accurately.
- Process and ship biological samples (IATA standards), maintain logs, and handle chain of custody.
- Enter and verify data in sponsor systems (EDC, IXRS, ePRO); resolve queries as assigned.
- Track investigational product, lab kits, and clinical supplies; ensure accountability records are current.
- Perform basic equipment oversight (centrifuge logs, ECG readiness, temperature monitoring).
- Collect, file, and support reporting of adverse events under CRC supervision.
- Assist with monitoring visits, audits, and regulatory/ethics submissions as required.
- Ensure delegated tasks, training records, and compliance with ICH-GCP, Division 5, TCPS2, and SOPs.

**Qualifications**:

- Bachelor’s degree in Life Sciences, Nursing, or Health Sciences.
- Clinical Research certification preferred.
- Phlebotomy certification an asset.
- IATA certification preferred or willingness to complete.
- Prior academic or hospital research assistant experience preferred.
- Experience with specimen handling, medical terminology, and EMR/EHR systems.
- Proficiency in Microsoft Office; experience with EDC platforms an asset.
- Strong organizational and documentation skills with attention to detail.
- Ability to manage multiple concurrent trials in a regulated environment.
- Clear, professional communication and comfort in patient-facing interactions.

**COVID-19 Vaccination Required.**

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

Expected hours: No less than 40 per week

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Clinical Research: 1 year (preferred)

Work Location: In person