Career Opportunities

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Category: Administrative Date Posted: 13-Jan-2022 End Date: 31-Jan-2022 ID: 1678
Director, Clinical Research Administration
Contact/Scientist: Debra Lynkowski
Program: Administration

The Ottawa Hospital: Inspired by research. Driven by compassion
The Ottawa Hospital Research Institute is the research arm of The Ottawa Hospital and an affiliated institute of the University of Ottawa. With more than 2000 scientists, clinician investigators, trainees and staff, and total revenues of over $110 million, we are one of the foremost Canadian hospital-based research institutes. We are investigating virtually every major disease and condition, with a focus on answering important health questions and translating our findings into benefits for patients and society.

Position Information:
Reporting to the Chief Operating Officer, the Director, Clinical Research Administration, is responsible for ensuring quality and compliance in research involving humans at The Ottawa Hospital (TOH) by overseeing all education, training and regulatory compliance aspects of human participant research.

The Director, Clinical Research Administration, will provide leadership to guide clinical research in alignment with the established mission, vision, values, and policies of TOH and OHRI. This position is broadly responsible for OHRI’s overall Quality Management System for Clinical Research.  Key areas of active involvement include Research Ethics Board operations, education and training for investigators, staff, and trainees, Health Canada regulatory submissions, compliance and inspection support, risk management, ensuring awareness and adherence to applicable legal and regulatory standards and guidelines including the current Tri-Council Policy Statement, International Council on Harmonisation Good Clinical Practice Guidelines, Health Canada regulations, PHIPA, corporate policies and standard operating procedures.  

Job Description:
The Director, Clinical Research Administration acts as the corporate lead for research involving humans and is responsible for developing and applying the associated policies and procedures that guide scientists and investigators, research staff and students. The Director will also organize or participate in, and provide support to several committees, as necessary, including Clinical Research Governing Council, Senior Management Team, Management Executive, as well as committees related to the Research Ethics Board, Clinical Research and Operations, Privacy and Safety.  This will also include regular meetings with clinician-researchers, clinical research managers and staff to ensure awareness of external regulations, internal policy, resource issues and other relevant clinical research matters.

The Director is the key liaison to TOH service departments and Nursing professional practice, and coordinates with key leaders the effective integration and delivery of clinical research services to support an outstanding cadre of clinical researchers.  

The Director has a leadership role in Privacy, working closely with the Director, Corporate Governance and Compliance and the Director, Human Resources and Research Administration.

The Director provides leadership to OHRI’s Research Ethics Office Manager and staff, Clinical Research Facilitators, Clinical Research Assistant, Senior Laboratory Technician, Biorepository Technician and administratively supports the REB Chair/Vice-chair; roles collectively responsible for the full scope of Clinical Research functions at the OHRI, including but not limited to:

•Training, compliance, monitoring and auditing
•Determining the ethical acceptability of research applications
•Privacy protections for use of information
•Regulatory submissions, correspondence and inspection support
•Data and Safety Monitoring/Reporting oversight for academic trials
•Sample collection, processing and storage
•Contingency planning and emergency preparedness
•Clinical Research communications to investigators and research staff
•Defining, collecting and interpreting data on operating metrics for clinical research and making recommendations for improvement

The Clinical Research Administrative team works closely with counterparts at varying levels at The Ottawa Hospital, University of Ottawa Heart Institute and the University of Ottawa, CHEO, Bruyere and other peer organizations, in the fulfillment of its goals and objectives.

The ideal applicant will have the following:
•Graduate degree in Allied Health, Nursing, Education, Business, Public or Health Administration, or another health-related field.
•Minimum of 10-15 years of progressive experience in clinical research at an academic research hospital/research institute, which includes management/leadership experience.
•Active affiliation with appropriate professional organization (e.g. SoCRA or ACRP certification).
•Progressive experience in the coordination of various types of studies, particularly regulated clinical trials, multi-centre trial coordination, industry-sponsored and academic investigator-led trial experience.
•Superior knowledge of TCPS2, ICH-GCP, PHIPA, Health Canada and FDA regulations.
•Knowledge of budget and contractual requirements for all types of studies.
•Knowledge of regulatory requirements for one or more therapeutic products including pharmaceutical drugs, biologics, natural health products and/or medical devices.
•Experience in the supervision of staff, inclusive of the interviewing and hiring process, performance management, attendance management.
•Superior knowledge of the responsible conduct of research and the mitigation of relationship management/conflict of interests.
•Knowledge of publication practices.
•Ability to analyze problems, develop solutions, make decisions, conduct risk management assessments and navigate complex environments.
•Ability to provide sound guidance to staff in numerous roles with varied education and experience.
•A flexible, proactive and collaborative approach in engaging stakeholders.
•Superior oral and written communication skills.
•Excellent planning, organizational, prioritization, and time management skills.
•Self-motivated, solid judgment, discretion, and interpersonal skills.

Preferred Qualifications:
•Bilingualism (French/English) is considered an asset
•Licensed Health Professional

Benefits and Opportunities:
We offer an attractive and equitable compensation package including comprehensive benefits package and a Defined Benefit Pension (DBP) plan.
Salary:
Hourly:         Min: $59.8593/hr. - Max: $81.663/hr.
or
Per Annum:  Min: $116,733 - Max: $159,243

Comments to applicants:
Qualified individuals interested in applying for this position should send a cover letter and complete CV with a description of experience (please submit all documentation in one pdf file labeled as follows:  Last name, First name) to: kadams@ohri.ca .

Contact Info:
Kim Adams, Director Human Resources and Research Administration
Ottawa Hospital Research Institute  
725 Parkdale Avenue, Ottawa, ON, K1Y 4M9


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.