Research Coordinator

The Clinical Research Coordinator’s purpose is to lead a team in the conduct of one or more research studies.

• Adhere to Good Clinical Practice and regulatory requirements and incorporate GCP requirements in all stages of research projects from start up to close up.
• Develop screening methods to identify eligible patients in consultation with front line health care staff
• Conduct recruitment of study participants including informed consent process, randomization and implementation of study protocol procedures.
• Schedule follow up with study participants as per study protocol
• Adhere to study timelines and milestones.
• Establish and implement site-specific procedures in accordance with regulatory requirements
• Ensure accurate and timely completion of Case Report Forms (CRF’s) as well as transmission of study data to the study sponsor using EDC systems such as RedCap
• Ensure secure and confidential collection and storage of all study data and related source documents.
• Respond to data-related questions and queries.
• Liaise with research pharmacist to manage drug supply for study participants.
• Arrange consultations with physicians as necessary.
• Complete local Ethics Committee applications, renewals and study closeout applications.
• Create and maintain investigator site file, logs and electronic files.
• Regular communication with clinical research team, hospital staff, lead study sites and external parties.
• Serious adverse event management and reporting.
• Host monitoring visits.
• Education of front line health care staff re: study protocol and procedures.
• Train and supervise additional team members to assist with study activities Qualifications
• Bachelor's degree in a relevant field of study.
• Minimum 3 years previous experience in multi-center research studies/clinical trials or other research projects.
• Experience with the management of large clinical research studies and or databases.
• Working knowledge of ICH-GCP Guidelines and international research requirements.
• Highly efficient computer skills, extensive experience with the Microsoft office suite.
• Supervisory experience and team coordination.

Assets: This position requires previous experience with orthopaedic surgical trials including Health Canada-regulated trials.

The successful candidate will ideally have SOCRA CCRP certification, as well as excellent communication skills and the ability to thrive in a fast-paced environment.