Altasciences
Clinical Quality Control Associate II
Altasciences, Overland Park, Kansas, United States, 66204
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 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
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!
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 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
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!