Quality Control Associate II

CareAbout•Overland Park, KS

42d

About The Position

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).

Requirements

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

Responsibilities

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.