Job Description

The Research Coordinator\xe2\x80\x99s purpose is to lead a team in the conduct of one or more research studies. The Research Coordinator is accountable to the Principal Investigator (PI) and or Program Manager (PM) and is responsible for all aspects of research projects highlighted below.

• Act as the primary contact for internal support departments and external stakeholders.
• Development and monitoring of study timelines.
• Provide coordination and direction in the development of data management methodologies for multiple studies; including key data management methods.
• Provide coordination and direction in the development of site management practices for multiple studies; including collection and maintenance of essential site documentation per ICH-GCP guidelines, management and preparation of regulatory and health authority documentation, research ethics board documents and study contact information.
• Engage in ongoing communication and coordinate regular meetings with key study specific stakeholders.
• Prepare presentations for external and/or internal meetings.
• Adhere to all related compliance, safety and monitoring.
• Prepare and revise all ethics and regulatory documents in accordance with the institution and regulatory and GCP guidelines.
• Coordinate communication with all internal and external collaborators.
• Coordinate training of study teams/centers on all aspects of clinical study procedures.
• Identify potential study participants, screen, randomize, coordinate and conduct follow-up and close-out visits according to study protocol ensuring subject safety (appropriate escalation and oversight by PI), maximal participant retention/compliance, and that timelines and protocol requirements are met optimally.
• Work collaboratively with nursing and physician staff in the applicable hospital departments for optimal study conduct.
• Assess for and report any AEs, SAEs or endpoints identified at the follow-up visits or anytime.
• Follow GCP guidelines for data collection, documentation, correction and Investigator review.
• Ensure Investigator review and sign off of study related documents completed within required timeframe.
• Enter data into CRF and respond to queries within required timeframe.
• Coordinate /perform site monitoring and site visits to confirm adherence to study protocol, procedures, ICH-GCP guidelines, local and national regulations and guidelines.
• Help develop research study budgets, in collaboration with PI\xe2\x80\x99s and other collaborators.
• Help administer multiple study and sub-study accounts.
• Negotiate budgets with vendors, sites and other collaborators.
• Support Principal Investigator(s) in preparation of proposals, grant budgeting and writing.
• Manage day to day study finance and study budgeting.

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 including TCPS2: CORE.
• Highly efficient computer skills, extensive experience with the Microsoft office suite. Proficient in Word, Power Point, and Excel.
• Supervisory experience and team coordination.
• Critical thinking, interpersonal, written and verbal skills

Assets:
The ideal candidate will have strong experience in launching and coordinating multicentre clinical trials and observational studies, direct patient interaction, food allergy, and experience with databases. Unconscious bias, Equity, Diversity, Inclusiveness, and Indigenous cultural safety training are additional assets.

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.

Hamilton Health Sciences