Clinical Quality Control Associate II

Altasciences; Overland Park (KS); On-site; USD 65,000 - 85,000; Full time

Job summary

Altasciences is seeking a Clinical Quality Control Associate II to perform QC review of clinical trial data and collaborate with the Quality Systems team to ensure compliance with study protocols, GCP, and SOPs.

The role emphasizes maintaining confidentiality, high-quality customer service, and mentorship within a fast-paced environment in Overland Park, KS. Applicants should have a high school diploma or GED, with a college degree preferred.

Qualifications

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

Responsibilities

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

Skills

Detail oriented

Good communication

Customer service focused

Quality control

Education

High School Diploma or GED

College degree preferred

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).

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