Clinical Research Facilitator - Ottawa, Canada - University of Ottawa Heart Institute

University of Ottawa Heart Institute

Verified Company

Ottawa, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Posted date

Wednesday, June 5, 2024
Deadline
Tuesday, June 25, 2024
Start date
As soon as possible
Competition number
ATF2425
Salary
Commensurate with experience and qualifications
Supervision
Manager, Clinical Research and ComplianceTerm

Two years.

Introduction

The Ottawa Heart Institute Research Corporation (OHIRC) is the research arm of the University of Ottawa Heart Institute. The Office of Clinical Research and Compliance is responsible for support of the clinical research enterprise.

We are currently expanding our team to enhance support and oversight around study conduct, including risk-based study monitoring and study start-up activities.

This position requires extensive experience in the clinical research environment.

Responsibilities:

The Clinical Research Facilitator will be responsible for activities primarily related to study conduct, including but not limited to:

Risk-based monitoring for investigator-initiated studies
Championing study startup support for investigatorinitiated studies (e.g., hosting study startup meetings as needed, providing guidance on monitoring plans and studylevel quality management system, recommending resources, etc.)
Developing relationships with clinical research staff and Investigators to provide guidance and support
Creating a reporting dashboard
Providing onboarding support to new clinical research staff and Investigators
Delivering education to clinical research staff, creating and developing templates and tools, and providing guidance on clinical research processes and compliance.
Oversight of clinical trials registration and maintenance in and user management
Participating in the orientation and training of new clinical research staff and Investigators
Assisting study teams with regulatory Trial Master File (TMF) setup
Serving as a member of the Clinical Research Standard Operating Procedures (SOPs) Committee
Attending meetings including monthly clinical research staff meetings, team meetings, Clinical Research Brainstorming Sessions, and meetandgreets with new Investigators
Conducting forcause study audits as needed
Providing support for Health Canada inspections and external audits

Basic requirements

Bachelor's degree in a health science related field or equivalent
Minimum 5 years of experience in clinical trial practices and protocols in an academic health care environment (preferred) or industry.
Experience monitoring complex clinical trials or similar experience or training
Experience managing international investigatorinitiated research studies
Extensive understanding of PHIPA, TCPS2, ICH-GCP Guidelines, and Health Canada regulations, with evidence of recent training
Strong computer skills, including experience with Microsoft Outlook, Word, Excel, PowerPoint and

Preferred qualifications

Clinical Research Certification (SOCRA or ACRP) or degree or certificate in clinical research
Experience using electronic data capture systems (i.e., REDCap, Dacima)
Knowledge of US FDA and other international regulations
Knowledge of GDPR requirements
Experience with the EPIC electronic health record system

Personal suitability

Highly motivated with the ability to work independently, managing competing priorities effectively to meet deadlines and expectations while remaining flexible and adapting to everchanging demands
Meticulous attention to detail, strong organizational and planning skills

- "Customer" service oriented (i.e., the clinical research community)

Excellent interpersonal skills with the ability to build strong relationships and work collaboratively with the research teams as well as colleagues in Research Administration
Excellent written and oral communication skills, including the ability to prepare and deliver presentations to various audiences
Ability to provide constructive criticism in a professional and educational manner
Strong conflict resolution skills
Ability to manage confidential information

To apply

The University of Ottawa Heart Institute is committed to ensuring barrier-free selection processes and work environments. Accommodations will be provided in all parts of the hiring process relating to any specialty requirements.

Please notify us of any accommodations that you require - any information you provide will be handled respectfully and in complete confidence.