Clinical Research Associate I / II

Thermo Fisher Scientific; Toronto; Remote; CAD 70,000 - 90,000; Full time

Job summary

A global leader in life sciences is seeking a Clinical Research Associate Level I / II to manage and monitor clinical trials from various sites. This role entails significant travel (up to 80%) and requires strong communication skills and a background in life sciences. Candidates must have a Bachelor's degree or equivalent certification and a keen attention to detail. Join a culture focused on innovation and integrity while making a meaningful impact.

Benefits

Competitive remuneration

Annual incentive plan

Healthcare benefits

Qualifications

• Minimal clinical monitoring experience equivalent to ~2 years in a clinical environment.
• Knowledge of ICH-GCPs and applicable regulations.
• Proficient in English communication.

Responsibilities

• Monitor clinical trials and ensure compliance with protocols.
• Conduct remote or on-site visits to assess site performance.
• Document observations and escalate issues to management.

Skills

Basic medical knowledge

Strong communication skills

Critical thinking

Attention to detail

Education

Bachelor’s degree in life sciences or RN certification

Tools

MS Office

Job description

Overview

Role: CRA Level I / II

Location: CAN Toronto - Remote

Work Schedule: Standard (Mon-Fri)

Environmental Conditions: Office

Experience Requirements:

• Previous Clinical Monitoring; on site or Remote (REQUIRED)
• Travel- up to 80% (REQUIRED)

Company: Thermo Fisher Scientific – description covers global impact in clinical trials, research development, and delivery of life-changing therapies; operations span laboratory, digital, and decentralized clinical trial services.

Location / Division Specific Information

Global Clinical Operations within PPD clinical research services provide end-to-end support for clinical trials from study start-up to monitoring through to study close-out across commercial and government contracts.

Discover Impactful Work :

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and / or monitoring environments. Acts as a site processes specialist ensuring trial conduct per protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects’ rights, well-being, and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities outlined in the task matrix.

A day in the Life :

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates deficiencies and issues to clinical management expeditiously and follows through to resolution.
• Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolve prior issues, and ensure timely data recording. Conduct monitoring tasks per the approved monitoring plan. Participate in investigator payments. Share responsibility with other project team members on issue resolution. Investigates and follows up on findings as applicable.
• Participates in investigator meetings; may help identify potential investigators with the client to ensure acceptability of qualified sites. Initiates clinical trial sites per procedures to ensure protocol compliance and regulatory and ICH-GCP obligations; makes recommendations as warranted. Performs trial close-out and retrieval of trial materials.
• Ensures essential documents complete and in place per ICH-GCP and applicable regulations. Conducts on-site file reviews per project specifications.
• Provides trial status tracking and progress updates to the team. Ensures study systems are complete, accurate, and updated per study conventions (e.g., CTMS).
• Facilitates effective communication between investigative sites, the client, and internal project teams. Responds to client and regulatory requirements/audits/inspections.
• Maintains administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to project work and process improvement initiatives as required.

Keys to Success :

Education

• Bachelor’s degree in a life sciences field or RN certification or equivalent and relevant formal qualification.

Experience

• Minimal clinical monitoring experience equivalent to ~2 years in a clinical environment; experience in clinical trials, medical terminology, clinical research or health care may be considered.
• Valid driver’s license where applicable.
• Equivalency may be considered (education + training + experience).

Knowledge, Skills, Abilities

• Basic medical/therapeutic area knowledge and medical terminology
• Working knowledge of ICH-GCPs and applicable regulations and procedural documents
• Strong oral and written communication with medical personnel
• Good interpersonal skills
• Customer-focused with strong listening, attention to detail, and ability to perceive underlying issues
• Organizational and time management skills
• Flexible and adaptable in varied scenarios
• Critical thinking and root-cause analysis for problem solving
• Risk-Based Monitoring concepts and processes
• Teamwork or independent work as required
• Proficient computer skills; MS Office and ability to learn new software
• Good English language and grammar skills

Work Environment

Thermo Fisher Scientific values health and well-being; this role may include exposure to healthcare or laboratory environments and up to 80% independent travel (car, plane, train).

Benefits

Competitive remuneration, annual incentive plan, healthcare, and a range of employee benefits. Innovative culture focused on integrity, intensity, involvement, and innovation.

Post-Posting Notes (Duplex content in French):

Details in French reiterate the role (CRA Niveau I / II) with location in Canada Toronto and similar experience requirements; content is a faithful translation of the English portion.

Employment Type : Full-Time

Experience : years

Vacancy : 1