Altasciences

Clinical Quality Control Associate II

Altasciences  •  United States (Onsite)  •  4 hours ago
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Job Description

About The Role

The Clinical Quality Control Associate II 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 II will conduct What You'll Do Here within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

What You’ll Do Here

  • 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.
  • Act as a mentor and coach the Quality Systems team members.
  • Record, track and ensure the resolution of data queries.
  • Assist in sponsor/regulatory audits.
  • May document and/or report clinical trial related deviations (i.e. SOP, protocol).
  • Identify and track error trends, report trends that may require re-training.
  • Compile data and maintain computerized files and/or update deviation tracking systems.
  • Understand protocol driven timed study events and acceptable collection windows (protocol and/or SOP driven) for the timed events.
  • Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
  • Complete and/or maintain training as required per jobs needs.
  • May provide departmental supervisors/managers with feedback for performance reviews.
  • Perform general administrative tasks when required.

What You’ll Need to Succeed

  • High School Diploma or GED and related work experience required; college degree and related work experience preferred.
  • Good communication, detail oriented, well organized, customer service focused, able to work in fast-paced environment.

What We Offer

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
  • Annual Performance Review

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Altasciences

About Altasciences

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!

Industry
Biotech & Life Sciences
Company Size
1,001-5,000 employees
Headquarters
Laval, CA
Year Founded
1995
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