Research Assistant I

7 months ago

Toronto, Canada BioPharma Services Inc. Full time

Position Summary:
Assist Clinical Research Coordinators in the execution of research activities to ensure conduct of clinical trials is in accordance with study protocol, BPSI SOPs and/or Directives, ICH-GCP and applicable regulatory guidelines. To act as a client/monitor facing BPSI ambassador during monitoring visits and support Project Management team in overall monitor/client satisfaction.

Duties and Responsibilities:

- Assists Clinical Research Coordinators with study related duties source document responsibilities (Study source document filing, binder organization, archiving, data entry of CRFs, scanning/redaction of source documents, and any administration-related assignments).
- Responsible for the accurate and timely preparation and maintenance of all study related source documents, including creation of study specific forms in paper and electronic format.
- Performs detailed review of source documents created and prepared by the Research Assistants [Study Source Document Templates (SSDTs) and/or Case Report Forms (CRFs)].
- Maintains adequate, accurate, complete, and legible records.
- Ensures the accuracy, timely and organized completion of assigned tasks within the Clinic in adherence to and compliance with the study protocol, SOPs, GCP and all regulatory requirements.
- Assists the Clinical Research Coordinator and BPSI Medical Writing groups with the regulatory binder maintenance.
- Coordinates with Project Management and Data Management groups to achieve milestones for project specific timelines.
- Ensures the quality of scanned documents are suitable for Data Entry.
- Hosts study monitors by coordinating with the CRC, PM, and the affected departments to ensure monitor/client expectations are met and exceeded (including preparing and assembling documents, booking the monitoring rooms, and any additional requests from the monitors/clients).
- Participates in clinical meetings and training sessions as required.
- Performs other clinic related tasks as assigned and as training and experience allow.

Qualifications:

- College diploma in sciences or equivalent.
- Certification in Clinical Research is an asset.
- Knowledge of ICH-GCPs and professional experience working in CRO preferred.
- Flexible hours depending on business requirements.
- Excellent interpersonal, communication and presentation skills.
- Excellent organizational skills with attention to detail, prioritization, and problem-solving skills.
- Proficient in MS Office (Word, Excel, PowerPoint, and MS Project).

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