Clinical Research Assistant II

The Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital – one of Canada’s largest learning and research hospitals. We are proudly affiliated with the University of Ottawa and supported by The Ottawa Hospital Foundation. With more than 2200 scientists, clinician investigators, trainees and staff, and total revenues of more than $120 million, we are one of the foremost Canadian hospital-based research institutes. Our research spans more than a hundred different diseases, conditions, and specialties with an overall focus on translating discoveries and knowledge into better health.

Job Description
The Clinical Investigation Unit (CIU) is looking for an experienced Clinical Research Assistant II to collaborate with investigators and the CIU team to assist with the research administration of clinical studies, especially the ethics review process. The CIU is a 12-bed clinical research facility located at the General Campus of The Ottawa Hospital.

Responsibilities include but are not limited to:

1. Patient recruitment, data collection, and/or analytical assistance.
2. Frequently aid in preparing regulatory applications, including research ethics board and Health Canada applications.
3. Facilitate the conduct of clinical research involving human subjects under the general direction of Scientists, Clinical Research Associates, and Research Coordinators who work with the Clinical Investigation Unit.
4. Provide administrative support to a centralized clinical trials office in the preparation and maintenance of Research Ethics Board and other regulatory documentation with the primary focus on completion of annual renewals, amendments, AE reports, IB Submissions, and regulatory documents.

Basic Requirements (Education/Experience):

1. Secondary school diploma.
2. Minimum 2 years’ experience in clinical research environment.
3. Evidence of training in Food and Drug Regulations, Division 5, and/or Device Regulations, as applicable.
4. Evidence of training certification in Tri-Council Policy Statement -2 (TCPS-2) and the International Council on Harmonisation – Good Clinical Practice Guidelines (ICH-GCP).
5. Ability to build and maintain internal and external professional relationships with patients, colleagues, and the multidisciplinary team.
6. Proven ability to work independently and navigate competing priorities.
7. Demonstrates initiative and resourcefulness in the development and implementation of projects and ability to evaluate progress, action areas of improvement.
8. Commitment to quality and excellence, attention to detail in ensuring compliance with the protocol.
9. Effective communication skills (written and oral).
10. Strong computer and data entry skills: including experience with electronic data capture.
11. Ability to manage multiple projects at once.
12. Flexibility to accommodate periodically demanding deadlines.

Preferred Qualifications:

1. Clinical research certification (ACRP or SOCRA).
2. Knowledge of IATA shipping regulations and basic laboratory procedures.
3. Experience in clinical medicine – Bilingualism is considered an asset.

Compensation Pay Range:
Min: $25.212/hr – Max: $33.615/hr

Comments to Applicant:
The position requires on-site work at The Ottawa Hospital’s General Campus during daytime hours. Individuals ready to meet the challenge of this position should submit a focused cover letter and curriculum vitae in a single PDF using the name convention “Last Name, First Name.”

Contact Info:
Name: Julia Chehaiber, MEBT, CCDP/AP
Title: Senior Research Operations Manager
Ottawa Hospital Research Institute
Address: 504 Smyth Road, Box 711, Ottawa, ON K1H 8L6
Email: jchehaiber@ohri.ca
Website: www.ohri.ca