Clinical Research Associate (Hybrid)

Insulet Corporation; Montreal; Hybrid; CAD 75,000 - 95,000; Full time

Job summary

A leading company in medical technology is seeking a Clinical Research Associate to support clinical activities for both domestic and international studies. This mid-senior level role involves collaboration with sites, training staff, and ensuring compliance with regulatory standards. The ideal candidate will possess a degree in a relevant field, CRA certification, and a history of effective communication and analytical skills, along with at least three years of clinical research experience.

Qualifications

• B.S. or B.A. degree or equivalent experience required.
• Minimum of 3 years of clinical research experience.
• CRA certification is necessary.

Responsibilities

• Conduct site qualification visits and collaborate on documentation creation.
• Train site staff on protocol requirements and data collection.
• Ensure study compliance and participate in report creation.

Skills

Analytical Skills

Detail Orientation

Interpersonal Skills

Communication

Organization

Education

B.S. or B.A.

CRA Certification

Job description

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Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Job Title : Clinical Research Associate

Department : QA Clinical

Position Overview

The Clinical Research Associate is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required.

Responsibilities

• Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
• Collaborate with Senior Clinical Research Associate to create source documentation / CRFs in alignment with protocol requirements.
• Create consent and assent templates specific to the needs of the planned study.
• Collaborate with sites and internal stakeholders to align and implement site specific language for each consent / assent.
• Train site staff on protocol requirements, source documentation, and case report form completion.
• Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent / assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
• Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
• Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
• Participates in team meetings and tracks action items.
• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Performs other duties as required.

Education And Experience

Minimum Requirements :

• B.S. or B.A. and / or an equivalent combination of education or experience.
• CRA certification
• Minimum of 3 years of experience.
• Available to travel on short notice and independently manage travel schedules.
• Direct experience in participating in the execution of clinical research studies.
• Must have analytical skill, be detail oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.
• Excellent written and effective verbal communication skills.
• Ability to communicate at all levels of an organization.
• PC skills; word processing, spreadsheet, database, Internet search and utilization.
• Flexible and able to work in a fast-paced environment.
• Team player.
• Ability to organize and judge priorities.
• Excellent ability to generate and maintain accurate records.

NOTE : This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x / week; may work remotely other days).

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Research, Analyst, and Information Technology

Medical Equipment Manufacturing

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