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 OHRI’s Thrombosis Program, under the direction of Dr. Gregoire Le Gal and the physicians affiliated with the Ottawa Hospital Thrombosis Program, is seeking an experienced Clinical Research Coordinator to manage investigator-initiated, international, multi-center regulated research trials.
Key responsibilities will include but not limited to regulatory correspondence (including requirements for Health Canada) contract negotiations, collection and tracking of essential documents, training, monitoring (source verification, data queries), safety reporting, CRF collection and data management, site communications, budget and financial tracking/reconciliation, scheduling and preparing reports for the Steering Committee, Adjudication Committee and Data Safety Monitoring Board meetings, etc.
As the project leader, you will be ensuring adherence to recognized guidelines and standards of clinical practice by all research staff with regards to patient recruitment, care, follow up and data management. This role may also involve local recruitment activities in support of other trials.
Key duties include overall coordination of study start-up and ongoing project management for each study site, patient recruitment and follow-up, data collection and data entry, preparing submissions for the research ethics boards, maintaining up-to-date regulatory files, facilitate physician oversight over study participants, ensure protocol adherence and regulatory compliance of day-to-day study activities.
Basic Requirements (Education/Experience):
•Minimum of 3 years of experience in a clinical research environment and a postsecondary degree or diploma
•A comprehensive understanding of the clinical research process from study start-up to completion
•Previous experience managing investigator-initiated, multi-center trials including communication with potential new sites, aiding new sites with study start-up activities, conducting site initiation, and training visits and ensuring sites are conducting trial in accordance with protocol and governing regulations through regular site monitoring.
•Evidence of training certification in Tri-Council Policy Statement -2 (TCPS-2) and the International Conference on Harmonization — Good Clinical Practice Guidelines (ICH-GCP) or a commitment to acquire upon being hired.
•Experience drafting study protocols and study documents.
•Experience submitting and managing REBs.
•Experience managing large data sets, issuing queries and queries resolution.
•Experience organizing and running Steering Committees, DSMB meetings and Adjudication Committee meetings.
•Strong computer literacy and experience using Microsoft Word, Teams, Outlook, Excel, and PowerPoint software.
•Great interpersonal skills and ability to communicate scientific research to study teams, patients and to the public (in-person and virtual)
•Strong ability to work in a fast-paced environment, with excellent communication and organizational skills.
•Able to work collaboratively and effectively as both part of an interdisciplinary team and independently.
•Attention to detail to ensure the accuracy of data and protocol requirements.
•Ability to build and maintain internal and external professional relationships with patients, colleagues, and the multidisciplinary team.
•Ability to manage multiple projects at one time.
•Proven ability to work independently and navigate competing priorities.
Preferred Qualifications:
•Knowledge of EPIC and TOH processes for arranging diagnostic imaging, investigational therapy, and patient follow-up visits
•Proficiency in English and basic knowledge of French
•Experience in running international, multi-center clinical research trials.
•Experience submitting to Health Canada
•Experience in project management
•SOCRA CCRP Certified
Contract Details:
This is a 1-year full-time contract with the possibility of renewal.
Salary: Min: $33.953 - Max: $48.957
Comments to Applicant:
Please provide your CV and a cover letter to clearly demonstrate how you meet the requirements of the position listed to:
Contact Info:
Name: Amanda Pecarskie
Title: Senior Research Program Manager
Program: Hematology
Ottawa Hospital Research Institute
Address: 501 Smyth Road, Ottawa Hospital - General Campus
Email: apecarskie@ohri.ca
The Ottawa Hospital Research Institute is committed to building and sustaining a welcoming and supportive culture that promotes equity, diversity and inclusion for trainees, researchers, and staff. We are devoted to identifying and removing barriers that limit equitable access to opportunities within our organization. The Ottawa Hospital Research Institute strongly supports initiatives that encourage the participation of all groups, in particular the four groups defined in the Employment Equity Act (women, Indigenous peoples, persons with disabilities and members of visible minorities).
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.
