Screening Quality Control Associate

Posted 4 Days Ago
Be an Early Applicant
Montréal, QC, CAN
In-Office
Entry level
Information Technology • Analytics • Biotech
The Role
Review and validate screening-phase clinical trial data for protocol, GCP, and SOP compliance; track and resolve data queries; verify participant eligibility; report trends, deviations, and complete documentation; assist screening activities and communicate issues to management.
Summary Generated by Built In

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.

We are better together and together We Are Altasciences.

About The Role

The Screening Quality Control Associate is responsible for reviewing and validating data collected during the screening phase of participant selection for clinical trials. This role ensures that all data complies with the study protocol, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOPs).

What You'll Do Here

  • Performing the live quality control (QC) of all data collected as part of screening and to ensure compliance to the study specific protocols and SOPs.

  • Ensuring all corrections to raw data and derived data are completed.

  • Ensure and advocate a high level of customer service and quality within the department.

  • Ensure the confidentiality of clinical trial participants and sponsors is respected.

  • Track data queries and ensure all corrections are completed in a timely manner.

  • Identify error trends and report trending to departmental management.

  • Answer QA findings, data management queries, generate DCRs and report deviations as necessary.

  • Verify participant eligibility.

  • Ensure screening activities and data was collected with the latest version of the clinical trial protocol.

  • Review of the Delegation of Authority log and assist in its completion where necessary.

  • Assist with screening activities when required.

  • Proactively communicate issues and/or problem resolutions to departmental management.

What You'll Need to Succeed

  • High School diploma required; college degree and related work experience preferred.

  • Excellent written and verbal communication in French and English.

  • Leadership, interpersonal and organizational skills.

  • Customer service focused, able to work in a fast-paced environment.

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 Screening 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

  • On site position at our Montreal office (1100 Beaumont); accessible by public transportation (Metro L'Acadie) and free parking lot for employees.

  • Candidates must be available between 9am and 7pm.

  • Flexibility to work overtime when necessary.

  • Usually one Saturday out of two (sometimes on Sundays).

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

  • Health/Dental/Vision Insurance Plans

  • 401(k)/RRSP with Employer Match

  • Paid Vacation and Holidays

  • Paid Sick and Bereavement Leave

Employee Assistance & Telehealth Programs

  • Altasciences' Incentive Programs Include: 

  • Training & Development Programs

  • Employee Referral Bonus Program

MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH

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!

Skills Required

  • High School diploma
  • College degree
  • Excellent written and verbal communication in French and English
  • Leadership, interpersonal and organizational skills
  • Customer service focus and ability to work in a fast-paced environment
  • Knowledge of Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)
  • Ability to verify participant eligibility and perform screening data QC
  • On-site availability in Montreal between 9am and 7pm, including alternating weekends and overtime
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The Company
HQ: Laval, Quebec
1,832 Employees
Year Founded: 1995

What We Do

Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!

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