Clinical Quality Control Associate II

Altasciences; Overland Park (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health/Dental/Vision

401(k) match

Paid vacation

Bereavement leave

Job summary

Altasciences in Overland Park, KS is seeking a Clinical Quality Control Associate II to perform QC review of clinical trial data and support the Quality Systems team in compliant tasks.

You will ensure confidentiality, maintain high quality standards, and assist in sponsor/regulatory audits while documenting deviations and data queries in line with SOPs and GCP.

Qualifications

• High School Diploma or GED required; college degree 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.
• 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.
• Complete and/or maintain training as required per jobs needs.

Skills

Communication

Attention to detail

Organizational skills

Customer service

Education

High School Diploma or GED

College degree preferred

Job description

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 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

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 #LI-JR1

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!