Research Project Coordinator II

Hamilton Health Sciences • Hamilton, ON

5h

About The Position

The Research Project Coordinator II coordinates and assists with the overall coordination in all aspects of a clinical study at PHRI. Responsibilities include: Plan study meetings and teleconferences including scheduling, tracking of attendee responses, assisting with travel arrangements if required and creation of meeting materials. Provide training and administer site management expectations to staff;. Track ongoing site IP usage and quantities using IP management system and/or supporting spreadsheets, shipments and create IP usage projection reports; Support the design and creation of outcome event adjudication forms and documents including event adjudication manual, event adjudicator training, decision forms, and reports; Coordinate site start-up process; Review and provide input and necessary documents for regulatory applications; oversee the management and reporting of data; Design, creation, requesting, and testing/validation of reports;.and support the implementation of various study management plans.

Requirements

• Undergraduate Degree in Biology, Health Sciences or Health Studies.
• Minimum 2 years’ experience in multi-centre research studies or equivalent experience.
• Experience with the management of large research datasets, preferably clinical data.
• Working knowledge of ICH-GCP Guidelines and international research requirements.
• Highly efficient computer skills, experience with the Microsoft Office suite, and electronic data capture systems such as iDataFax or TrialMaster.
• Broad knowledge of research methodology, clinical trials, and drug development processes.
• Highly developed communication skills including the ability to problem solve and think critically.

Responsibilities

• Plan study meetings and teleconferences including scheduling, tracking of attendee responses, assisting with travel arrangements if required and creation of meeting materials.
• Provide training and administer site management expectations to staff.
• Track ongoing site IP usage and quantities using IP management system and/or supporting spreadsheets, shipments and create IP usage projection reports.
• Support the design and creation of outcome event adjudication forms and documents including event adjudication manual, event adjudicator training, decision forms, and reports.
• Coordinate site start-up process.
• Review and provide input and necessary documents for regulatory applications.
• Oversee the management and reporting of data.
• Design, creation, requesting, and testing/validation of reports.
• Support the implementation of various study management plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level