Clinical Quality Control Associate II

Altasciences; Overland Park (KS); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health/Dental/Vision

401(k) Plan

Vacation & Holidays

Telehealth & EAP

Job summary

Altasciences is seeking a Clinical Quality Control Associate II in Overland Park, KS to perform QC reviews of clinical trial data in line with protocol and regulatory guidelines. The role supports the Quality Systems team and ensures adherence to GCP and SOPs.

Responsibilities include tracking data queries, assisting in audits, and maintaining thorough documentation. Strong communication and meticulous attention to detail are essential in a fast-paced environment.

Qualifications

• QC review of clinical trial data per protocol and SOPs.
• Record and track data queries and deviations.
• Assist sponsor/regulatory audits.

Responsibilities

• Perform QC reviews of clinical trial data per protocol.
• Record, track, and resolve data queries.
• Assist sponsor/regulatory audits.
• Maintain documentation and deviation logs.

Skills

QC review

Data integrity

GCP compliance

SOP adherence

Documentation

Communication

Mentoring

Education

GED/High School Diploma

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).

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 bothat and outside of work.

Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and HolidaysPaid 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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