Job Description

• Conduct routine and directed audits and monitoring visits using a risk-based approach, to verify compliance and quality assurance and report findings as per established process
• Educate clinical researchers regarding the regulations, guidelines, and best practices for the conduct of clinical research
• Conduct review process and assist with regulatory applications for all investigator-initiated regulated research
• Conducts investigator and staff responsibilities meetings to ensure oversight of trials
• Assist investigators with preparation for external audits and regulatory inspection process
• Organization and implementation of various training sessions, site auditing or monitoring visits for OHRI led clinical trials, other research related meetings and events
• Provide leadership and direction to clinical research staff including advising and educating staff to ensure a complete understanding of the conduct of clinical research and related regulations, Research Ethics Board process, guidelines and best practices
• Train and advise coordinators on the day-to-day operation of research and data collection activities, Good Documentation Practice, ICH-GCP, regulatory and ethical issues
• Support clinical research staff and investigators with maintaining clinical research documents, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies
• Facilitate efficient study start up process
• Assist with development, management, training and promotion of Standard Operating procedures for Clinical Research
• Liaise with research team members (locally and/or at study sites), OHRI Grants, Research Ethics Board staff, Contracts and Finance staff, Research Pharmacy staff, study sponsors and others as required
• Identify ongoing education and support needs of clinical research staff and investigators
• Sit as a contributing member on various committees (CORC, N2, Research Connect, etc.)
• Other Clinical Research related duties as required

Basic Requirements (Education/Experience):

• Bachelor’s Degree and/or a health professional designation
• A minimum of 5 years’ experience in clinical research is required, including coordinating/managing clinical trials
• Experience in monitoring, auditing or inspection activities or a combination of relevant education and training
• Demonstrates strong understanding of and has Certificates demonstrating competency in Tri-Council Polity Statement (TCPS2) – Ethical Conduct for Research Involving Humans and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – Guideline for Good Clinical Practice (ICH-GCP, E6, R2) and other relevant guidelines that apply to the clinical research field
• Knowledge of Clinical Trials Applications, Canadian Regulations Part C Division 5, Part 4 (Natural Health Products) and Part 3 (Medical Devices), United States Code of Federal Regulations (CFR), clinical trial registration, etc.
• Current Clinical Research Certification (ACRP or SOCRA)
• Experience in delivering presentations
• Excellent organizational and communication skills (written and oral)
• Advanced skills in Microsoft Office programs, may include knowledge of statistical packages
• Ability to prioritize work and meet deadlines in changing, multiple demand setting
• Ability to work independently with minimal supervision and enjoy working as a member of a team
• Able to travel periodically

Preferred Qualifications:

• Experience coordinating multicenter and international trials preferred
• Knowledge and experience with OHSN-REB and CTO applications
• Experience using the electronic health information system, Epic
• Bilingualism

Contract Details:
This is a full-time position
Salary: Min: $40.622/hr. – Max: $51.628/hr.

Comments to Applicant:
Individuals ready to meet the challenge of this position with relevant experience should submit a focused cover letter and curriculum vitae in a single PDF using the name convention “Last Name, First Name” to:

Contact Info:
Penny Phillips
Director, Clinical Research Administration
Email: clinicalresearchadmin@ohri.ca

We thank all applicants for their interest. However, only those invited for an interview will be contacted. The Ottawa Hospital Research Institute is an equal opportunity employer. Upon request, accommodations due to a disability are available throughout the selection process.