Clinical Quality Control Associate II

220 Altasciences Company Inc; Montreal; On-site; CAD 55,000 - 75,000; 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

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 ensuring compliance with GCP and SOPs.

This on-site role requires strong attention to detail, fluency in French and English, and the ability to manage multiple tasks in a fast-paced setting, including preparing deviations and contributing to training activities.

Qualifications

• High School Diploma completed.
• Fluent in French and English.
• Detail oriented and customer-service focused.
• Ability to work in a fast-paced environment.

Responsibilities

• QC review of clinical trial data in line with GCP and SOPs.
• Record, track and resolve data queries and deviations.
• Report and escalate errors or trends as needed.
• Maintain confidentiality of trial participants and sponsors.
• Mentor QA team members and support data systems.
• Support timely study events and SOP-driven windows.

Skills

Bilingual French-English

Attention to detail

Communication skills

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 offers a wide range of benefits to help employees live healthy and satisfying lives, both on and off the 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 programs
• Altasciences' incentive programs include Training and development programs
• Employee orientation bonus program
• Annual performance reviews #LI-JG1

Altasciences is an equal opportunity employer committed to diversity and inclusion.

Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation.

Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.

Join us at Altasciences!