Research Assistant I - Toronto, Canada - BioPharma Services Inc.

BioPharma Services Inc.

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 administrationrelated 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 problemsolving skills.
Proficient in MS Office (Word, Excel, PowerPoint, and MS Project).
Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs._