Clinical Research Assistant II

BioTalent Canada; Ottawa; On-site; CAD 60,000 - 78,000; Full time

Job summary

The Ottawa Hospital Research Institute is seeking a Clinical Research Associate to support consent-related research in clinical trials. You will participate in a team, engage with patients and caregivers, analyze data, and assist with manuscript preparation and submission.

Ideal candidates bring a clinical research background, TCPS-2/ICH-GCP training, and proficiency with regulatory requirements such as TCFR and IRB processes.

Qualifications

• 2 years of experience in a clinical research environment with a secondary diploma.
• Experience coordinating and managing clinical trials.
• Evidence of TCPS-2 and ICH-GCP training.
• Training in Food and Drug Regulations and/or Device Regulations as applicable.
• Strong computer skills with Zoom, MS Teams, etc.
• Excellent English written and verbal communication.

Responsibilities

• Participate in a team conducting research on consent issues in clinical trials.
• Involve patient-facing activities, data analysis, and manuscript management.
• Collaborate with investigators and study staff to support trial activities.

Skills

TCPS-2 training

ICH-GCP training

Regulatory knowledge

Teleconferencing tools

Interpersonal skills

Communication skills

English proficiency

Education

Secondary diploma

TCPS-2 certification

ICH-GCP certification

Food/Drug/Device regs training

Tools

Epic EMR

REDCap

Job description

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 individual will participate within a team conducting research on consent issues in clinical trials. The role will involve patient-facing activities, data analysis, and manuscript management.

Basic Requirements (Education/Experience):

• 2 years of experience in a clinical research environment and a secondary diploma.
• Experience coordinating and managing clinical trials.
• Evidence of training certification in Tri-Council Policy Statement -2 (TCPS-2) and the International Conference on Harmonization – Good Clinical Practice Guidelines (ICH-GCP)
• Evidence of training in Food and Drug Regulations, Division 5, and/or Device Regulations, as applicable
• Strong computer skills, in particular teleconferencing with Zoom, MS Teams, etc.
• Superior interpersonal skills
• Experience and comfort with patients and caregivers
• Excellent English written and verbal communication skills

Preferred Qualifications:

• Experience coordinating a regulated multi-centre clinical trial
• Experience with clinical trial monitoring
• Experience with Epic EMR
• Experience with Redcap

This is a full-time contract.

This position is for an existing vacancy. Artificial Intelligence (AI) will not be used to screen, assess, or select applicants for this position.

Contact Info:

Name: Brian Dewar

Title: Clinical Research Associate

Ottawa Hospital Research Institute

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.