Clinical Quality Control Associate II

Contenido de trabajo

Altasciences is a mid-size contract research organization with a unique focus on supporting drug development from lead candidate selection to proof of concept. With over 25 years of industry experience, we provide preclinical and clinical solutions to an international customer base of biopharmaceutical companies. Our full-service offering in this critical stage of drug development includes program management, preclinical safety testing, clinical pharmacology services, manufacturing and analytical services, medical writing, biostatistics, data management, and bioanalysis services tailored to specific research requirements. Altasciences has facilities in Montreal, QC; Kansas City, KS, Seattle, WA, and Philadelphia, PA.
Our team is made up of over 1,300 professionals from the medical and scientific fields who work together to
achieve a common goal: to contribute to the advancement of life sciences. Bring your talents and forward-thinking approach to Altasciences and help us develop medicines for those who need them, faster.

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 tasks performed within compliance of study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

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.
• Other tasks as assigned by management

Qualification:
Educational:
High School Diploma or GED and related work experience required; college degree preferred.

Skills:
Good Communication (French and English), detail oriented, well organized, customer service focused, able to work in fast-paced environment.

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!