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Clinical Research Associate
4 months ago
Clinical Research Associate (based in Montreal)
**Clinical Research Associate (based in Montreal)**
Position open to Canadian citizen
esident or with Canadian work permit
Montreal Health Innovations Coordinator Center
Full Time
The Montreal Health Innovations Coordinating Center (MHICC) is a full service contract research organization targeted on multicenter and multinational clinical trials. We provide services to the academic community and to the pharmaceutical, biotechnology and medical device industries. Our main goal is to establish a partnership with our customers to ensure a successful implementation of their project while respecting the scope of work, budget, timelines and highest standards of quality.
***
The CRA is responsible for monitoring the progress of clinical studies at sites or remotely, and ensure clinical studies are conducted, recorded, and reported in accordance with the protocol, monitoring plan, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and other applicable regulatory requirements. This position interacts with investigators, study coordinators, pharmacists and other clinical personnel, Project Managers, and sponsors.
- Monitor clinical studies at sites or remotely for compliance with the protocol, monitoring plan, SOPs, GCP and other applicable regulatory requirements and in accordance with the study timelines
- Perform pre-study, site initiation, monitoring and close-out activities
- Review clinical data, source documentation, case report form and site regulatory files for accuracy, completeness and compliance
- Prepare and submit monitoring reports and follow-up letters to the Project Manager per timelines; follow-up on site corrective actions until resolution
- Manage assigned sites to ensure compliance & adequate enrollment
- Serve as a resource and main point of contact for study coordinators, investigators & other staff
- Participate in training
- Provide training and inform sites of any changes in study conduct and requirements
- Communicate with the site, sponsor and Project Manager, and ensure critical observations are immediately communicated and effective resolution is obtained
- Work with data management and the site to resolve discrepancies
- Ensure appropriate reporting & follow-up for all safety information by site staff
- Proactively identify and provide input into issues that may impact recruitment timelines
- Ensure audit/inspection readiness at sites and assist with inspection preparation
- Perform administrative functions (e.g. planning/scheduling, tracking time on clinical studies, expense reports, etc.
**REQUIREMENTS**
- Bachelor’s degree in health sciences or nursing (mandatory);
- Bilingual (French/English) (mandatory);
- A min. of two (2) years clinical research monitoring and/or clinical study coordination;
- Detailed oriented;
- Excellent knowledge of clinical research methodology and solid understanding of clinical studies, ICH, GCP, and other applicable regulatory requirements;
- Strong leadership, project management and interpersonal skills;
- Must have strong analytical and problem-solving skills;
- Prioritize effectively;
- Computer literacy and proficient in Microsoft Office including Excel;
**WORK CONDITIONS**
- 35 hours weekly base
- Pre-approved overtime paid
- Flexible work schedule for work-family balance
- Hybrid model (working from home and office)
- 4 weeks’ vacation after one year
- 13 statutory holidays
- Defined retirement benefits
- Group insurance
- 9.6 day off sick days
- **May require some travel, approx. 25-35%**
**_The Montreal Heart Institute_**_ offers a wide range of benefits aimed at employees' health, well-being and quality of life at work, including free access to the EPIC Centre, Recharjme cabins and silence rooms, as well as various other benefits._
**TO SUBMIT YOUR APPLICATION**
We offer equal employment opportunities to all.
