Description
We are seeking a Clinical Research Coordinator to join our team in Mississauga, Ontario, Canada. As a Clinical Research Coordinator, you will perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Responsibilities
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assist with periodic review of study files for completeness.
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
- May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Qualifications
- High School Diploma or equivalent required.
- 3-4 years administrative support experience.
- Equivalent combination of education, training and experience.
- Minimum one year clinical research experience strongly preferred.
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
- Written and verbal communication skills including good command of English language.
- Effective time management and organisational skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Basic knowledge of applicable clinical research regulatory requirement, i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines as provided in company training.
- Knowledge of applicable protocol requirements as provided in company training.
Benefits IQVIA is an equal opportunity employer and is committed to creating a diverse and inclusive environment. We offer accommodations for applicants with disabilities and encourage you to disclose any needs during the recruitment process.
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