Clinical Quality Control Associate II
- Laval, QC, Canada
- Montreal, QC, Canada
Full-time
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Job details
- Job type
- Full-time
- Working hours
- 37.5 hours a week
- Posting language
- English
- Posted
Original 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 escalate (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.
Altasciences benefits include
- 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
More about this job
Responsibilities
The Clinical Quality Control Associate is responsible for conducting quality control reviews of clinical trial data to ensure compliance with study protocols, GCP, and SOPs. They also track and resolve data queries, document deviations, and provide mentorship to the Quality Systems team.
Requirements
Candidates must have a high school diploma and strong attention to detail, with proficiency in Microsoft Office. The role requires fluency in English and the ability to work in a fast-paced, on-site environment in Montreal.
Skills
- Quality control
- Clinical trial data review
- GCP compliance
- SOP adherence
- Data query resolution
- Deviation tracking
- Microsoft Office
- Attention to detail
- Customer service
- Communication
- Mentoring
- Confidentiality management
- Time management
- Problem solving
- Initiative
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- RRSP with employer match
- Paid vacation
- Statutory holidays
- Paid sick leave
- Bereavement leave
- Employee assistance program
- Telehealth programs
- Training and development programs
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Science & Research
- Administrative
Keywords
- Clinical Quality Control
- Clinical Trials
- GCP
- SOP
- Data Management
- Quality Systems
- Protocol Compliance
- Deviation Tracking
- Microsoft Office
- Regulatory Agencies
- Clinical Research
- Quality Assurance
- Data Integrity
- Customer Service
- Mentorship