Research Project Coordinator II

Socket.dev; Hamilton; On-site; CAD 60,000 - 80,000; Full time

Job summary

PHRI is seeking a Research Project Coordinator II to support clinical studies in a dynamic research environment. You will coordinate meetings, assist with site training, and manage IP usage while supporting regulatory submissions and data reporting.

The role requires an undergraduate degree in biology or health sciences, at least two years of multi-centre study experience, and strong data management and communication abilities.

Qualifications

• Undergraduate degree in Biology, Health Sciences or Health Studies.
• Minimum 2 years’ experience in multi-centre research studies.
• Experience managing large research datasets, preferably clinical data.
• Working knowledge of ICH-GCP Guidelines and international research requirements.
• Proficient in Microsoft Office and electronic data capture systems such as iDataFax or TrialMaster.
• Broad knowledge of research methodology, clinical trials, and drug development.
• Strong communication and problem-solving skills.

Responsibilities

• Coordinate and assist with all aspects of a clinical study at PHRI.
• Plan study meetings and teleconferences; schedule attendees and arrange travel if needed; create meeting materials.
• Provide training and administer site management expectations to staff; track IP usage and create projection reports.
• Support design and creation of outcome event adjudication forms and documents; training and reports.
• Coordinate site start-up process and review regulatory documents; oversee data management and reporting.
• Design, request, and test/validate reports; support implementation of study management plans.

Skills

Communication skills

Problem solving

Microsoft Office

iDataFax

TrialMaster

Data management

Regulatory knowledge (ICH-GCP)

Clinical trials knowledge

Education

Undergraduate degree in Biology, Health Sciences or Health Studies

Job description

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.