About this role
We’re hiring a Bilingual Clinical Research Associate for a big pharmaceutical company in Montreal. This is a permanent full-time position with our client.
The Clinical Research Associate II (CRA II) is a site management and monitoring expert on the extended Global Study Team. The CRA II is accountable and responsible for all aspects of site management and monitoring activities for assigned applicable Phase I – IV studies and clinical investigator sites within the approved Clinical Development Plan (CDP). These global, complex studies are conducted within the standard operating procedures set in the company, according to Good Clinical Practices (ICH-GCP), and applicable regulatory and legal requirements.
- CRA II is responsible for Monitoring, using available IT systems, tools, and expertise to ensure the Investigator and site staff meet all aspects of study delivery and commitments from site selection through close out. This includes, but is not limited to, ensuring the following key areas of focus:
- Adequate site resources for conduct of the study including staff, facilities, and equipment.
- Proper training and qualifications for all site staff participating in the study.
- Proper control, storage, dispensation, patient compliance, and accountability of Investigational Product.
- Appropriate Regulatory and Legal approvals are in place throughout the conduct of the study.
- Site enrollment commitments are on track with enrollment plan
- Data integrity, quality, and timely resolution of all queries.
- Documentation and timely resolution of all action items which could negatively impact study deliverables.
- All adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
- Responsible for preparing and conducting onsite and/or remote monitoring visits according to monitor plan, including complete reporting and follow up for all monitoring visits.
- Rigorous regulatory guidelines exist to ensure overall patient safety, related to reporting of serious or unexpected adverse drug reactions. The CRA II is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting as well as monitoring ongoing compliance.
- Due to the highly regulated clinical trial environment, the CRA II must proactively identify potential issues and assist the project team in the development of site Corrective Action/Preventative Action Plans (CAPAs) if required. The CRA II ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
- As a key contributor to the paper or electronic Trial Master File (TMF) and study documents at the country and site level, the CRA II ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File with an expectation to be Inspection Ready at all times.
- Incumbent is a member of the audit/regulatory inspection team and a key contributor in the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.
- As a result of their experience and expertise, the CRA II may be a mentor and role model for new or less experienced CRAs on process, study, technical, and behavioral competencies.
- The CRA II works in close collaboration with the Country Lead Monitor (CLM) and Study Lead Monitor (SLM) for internally monitored and outsourced clinical trials.
- The CRA II is the site manager and directly ensures patient safety as well as the quality and compliance of clinical trial data for Regulatory Approvals of a drug. Critical breakage or non-compliance with regulations or ICH-GCP principles in the conduct of a study may lead to halting or rejection of the drug marketing approval by invalidating patient data of clinical trials that supports the marketing application.
- The CRA II is the first contact of the company with the customer (physician, MD), therefore establishes and maintains customer essential relationships from development of study drugs and even after they are in the market.
- In addition to the value above, CRAII is expected to have ability to take site management activities for sites which are challenging to manage, and have higher capacity to take more site assignments or take sites in complex studies
- Must have a Healthcare related Bachelor’s Degree;
- At least 3 years of experience as CRA;
- Awareness & understanding of cultural and regional operational differences.
- Effective written and verbal English/French communication skills.
- Oral presentation & interpersonal skills.
- Decision making.
- Issue resolution.
- Planning and organization, time management, prioritization.
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- Motivation Letter (optional)
Any questions remaining?
Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Calgary
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