POSITION:

Clinical Research Coordinator – Phase 1

LOCATION:

BIOVAIL CONTRACT RESEARCH – SCARBOROUGH, ON

Associate Director, Clinical Operations

POSITION DESCRIPTION:

• Coordinate and manage all clinical aspects of assigned studies from study initiation to close-out, ensuring supplies, essential documents are prepared and sufficient resources are in place to execute studies.

• Primary project assignments will include more complex studies (i.e. Phase  I- Phase IV studies, first in man and  innovator) 

• Review protocols for accuracy, feasibility and resources and provide clinical input.

• Prepare, review and maintain study specific documents including source documentation, CRFs and other study related materials. 

• Monitor clinic conduct to ensure that activities are carried out in compliance with protocol, SOPs and GCP regulations.

• Manage issues with volunteers, staffing and other study associated query resolution

• Provide leadership and support for study personnel including preparation of study briefings and conducting study initiation meetings as required.

• Assist with the recruitment and selection process of Clinical Research Coordinator candidates as well as the training and development of new hire Clinical Research Coordinators and or technical staff.

• Participate in training as required, maintain training records and read all applicable SOPs in a timely manner with appropriate documentation completed

• Maintain and communicate up-to-date study information and strategies to Project Managers and divisional management.

• Additional tasks may also be assigned based on training and qualifications i.e. vital signs, blood collection, training etc.

QUALIFICATIONS & EXPERIENCE:

• A minimum of a post-secondary degree or diploma in a healthcare related discipline.
• Certified Registered Nurse, preferred
• 2-3 years previous clinical research experience in CRO/pharmaceutical industry required including experience in more complex studies (i.e. Phase I – Phase IV) or equivalent.
• Sound knowledge of research principles, ICH/GCP guidelines and applicable regulations
• Recognized certification in clinical research (e.g. ACRP or SoCRA) preferred
• Demonstrated experience with MS office (Word, Excel, Project, Outlook, PowerPoint)

jobs@biovail.com