Clinical Quality Control Associate II

Altasciences Company; Montreal; On-site; CAD 52,000 - 68,000; Full time

Benefits offered by this job

Health/dental/vision insurance plans

RRSP with employer match

Paid vacation and statutory vacations

Paid sick leave and bereavement leave

Employee assistance and telehealth

Training and development programs

Employee orientation bonus program

Annual performance reviews

Job summary

Altasciences in Montreal is seeking a Clinical Quality Control Associate to perform QC review of clinical trial data and support the Quality Systems team in QC tasks. You will ensure compliance with study protocols, GCP and SOPs while maintaining high standards of data integrity and customer service.

The role requires bilingual communication (French and English), strong attention to detail, and the ability to manage multiple priorities in a fast-paced environment.

Qualifications

• High School Diploma completed.
• Related work experience an asset.
• Good communication in French and English.
• Detail oriented, well organized, customer service focused, able to work in fast-paced environment.
• Software: Microsoft Office.

Responsibilities

• Report, track and elevate errors and trends.
• Compile data and maintain computerized files and deviation tracking systems.
• Record, track and ensure resolution of data queries.
• Proactively communicate issues and resolutions to supervisors.
• Ensure confidentiality of trial participants and sponsors.
• Maintain high quality and customer service within the department.
• May report deviations related to SOPs or protocols.
• Mentor and coach Quality Systems team members.
• Understand protocol-driven events and collection windows.
• Other tasks as assigned by management.

Skills

Bilingual French/English

Detail oriented

Strong communication

Customer service oriented

Self-motivated / initiative

Ability to lift up to 25 pounds

Education

High School Diploma

Tools

Microsoft Office

Job description

About The Role

The Clinical Quality Control Associate is responsible for the quality control (QC) review of clinical trial data and working with the Quality Systems team to complete QC related tasks. The Clinical Quality Control Associate will conduct tasks performed within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

What You'll Do Here

• Report, track and elevate (if necessary) errors and/or trends that may require re-training, as required by location.
• Compile data and maintain computerized files and/or update deviation tracking systems.
• Record, track and ensure the resolution of data queries.
• Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Maintain and advocate a high level of quality and customer service within the department.
• May document and/or report clinical trial related deviations (i.e. SOP, protocol).
• Act as a mentor and coach the Quality Systems team members.
• Understand protocol driven timed study events and acceptable collection windows (protocol and/or SOP driven) for the timed events.
• Other tasks as assigned by management.

What You'll Need to Succeed

• High School Diploma completed.
• Related work experience an asset.
• Good Communication in French and English.
• Detail oriented, well organized, customer service focused, able to work in fast-paced environment.
• Software: Microsoft Office.
• Strong attention to details
• Personal/professional integrity and proven discretion in handling confidential information.
• Ability to develop strong trusting relationships in order to gain support and achieve results.
• Capable of managing multiple conflicting priorities.
• Must be self-directed, motivated and have a willingness to take initiative.
• The candidate must be able to lift up to 25 pounds.

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Clinical Quality Control Associate including, but not limited to, for the following reasons: The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.

What We Offer

Regular full-time position; 37.5 hours a week.

Candidate needs to be available between 7am and 7pm and 1 every 3 week-ends.

On site, Montreal site (1200 Beaumont).

Accessible by metro (L'Acadie); Free parking for employees.

Altasciences benefits

• Health/dental/vision insurance plans
• RRSP with employer match
• Paid vacation and statutory vacations
• Paid sick leave and bereavement leave
• Employee assistance and telehealth programs

Altasciences incentive programs include

• Training and development programs
• Employee orientation bonus program
• Annual performance reviews