Research Project Coordinator II

Original job posting

The Research Project Coordinator II manages clinical study logistics, including meeting coordination, site management, and IP tracking. They also support regulatory documentation, data reporting, and the creation of outcome event adjudication materials.

Job details

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 1. Undergraduate Degree in Biology, Health Sciences or Health Studies. 2. Minimum 2 years’ experience in multi-centre research studies or equivalent experience. 3. Experience with the management of large research datasets, preferably clinical data. 4. Working knowledge of ICH-GCP Guidelines and international research requirements. 5. Highly efficient computer skills, experience with the Microsoft Office suite, and electronic data capture systems such as iDataFax or TrialMaster. 6. Broad knowledge of research methodology, clinical trials, and drug development processes. 7. Highly developed communication skills including the ability to problem solve and think critically.

What you’ll do

The Research Project Coordinator II manages clinical study logistics, including meeting coordination, site management, and IP tracking. They also support regulatory documentation, data reporting, and the creation of outcome event adjudication materials.

Requirements

Candidates must hold an undergraduate degree in Biology, Health Sciences, or Health Studies and have at least 2 years of experience in multi-centre research. Proficiency in ICH-GCP guidelines, research methodology, and electronic data capture systems is required.

Listed skills

• Problem solving · Preferred
• Communication · Preferred
• Microsoft Office · Preferred
• Critical Thinking · Preferred
• data management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical study coordination
• Site management
• Regulatory applications
• Data management
• ICH-GCP guidelines
• Research methodology
• Clinical trials
• Drug development
• Microsoft Office
• Electronic data capture
• iDataFax
• TrialMaster
• Communication
• Problem solving
• Critical thinking
• Management Plans
• Research
• Adjudication
• Biology
• Management
• Spreadsheets
• Clinical Trials
• Computer Literacy
• Critical Thinking
• Drug Development
• Electronic Data Capture (EDC)
• Health Sciences
• Good Clinical Practices (GCP)
• Problem Solving
• Research Methodologies
• Travel Arrangements
• Scheduling
• Coordinating

Job areas

• Science & Research
• Healthcare
• Administrative
• Research Project Coordinator
• Project Coordinator
• Statistical, Mathematical and Related Associate Professionals
• Project Management Specialists