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Quality Control Specialist

Location
Lincoln, Nebraska
Salary
$17.00 Per Hour
Job Type
Permanent
Posted
30 Jul 2022
JOB DESCRIPTION

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

Purpose:

As a Quality Control Specialist you are responsible for the review and verification of all source data. Conduct data reconciliation and final check of data. Conducts final quality check and reviews source documentation. Ensures the completeness, accuracy and consistency of source data so that it meets the standards of quality expected for reporting to Sponsors and regulatory bodies. Participate with multidisciplinary teams involved in setting up, conducting and reporting clinical trials. This is a full time position that starts at $17/hour.

Essential Functions:

For all assigned studies, ensure the following:

Attend internal study initiation meeting and meet with Clinical Data Manager (CDM) and Clinical Study Manager (CSM) to determine Quality Control (QC) criteria and timelines for each study
Ensure QC reviews are completed in accordance with study specific timelines
Ensure consistent and complete review of source data by completing a Study Information Document indicating all study specific QC review requirements
Meet with CDM and CSM to review any study specific source data forms prior to study start to ensure completion, accuracy, and ability to capture study information required to complete the study specific CRFs and required by the study protocol and Celerion SOPs/PGs
Prepare and manage study materials including but not limited to Source Data Storage Binder /Files
Review source data on an ongoing basis to ensure the following:
Medical history and ICF data is complete according to GCP and FDA guidelines and all subjects meet study eligibility criteria according to the study protocol
Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs/PGs
All deviations and documentation errors are sent to clinical staff for correction and updates as applicable
Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGs
Complete a Final QC to ensure all source data is accounted for and has been QC reviewed
Compile and sort all screening failures - not on study (NOS) - data
Archive study source documents (as needed)
JOB REQUIREMENTS

Knowledge/Skills/Education/Licenses:

High School Diploma or GED/A Level required (relevant internal Celerion experience in lieu preferred) and 1-2 years industry experience preferred

Previous QC or related experience preferred
Medical Terminology Training preferred
Excellent oral and written communication skills
Ability to organize and manage multiple priorities
Experience working in an environment with complex processes and defined criteria
Excellent time management
Proficient in MS Office applications required

Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

As a leader in translational medical research, Celerion considers COVID safety to be of paramount importance. In addition to contributing to COVID vaccination trials and related research, we have implemented strict protocols to ensure the safety of our onsite associates and study participants. We continue to refine our approach and processes as CDC guidance and our understanding of the virus evolves.
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Details

  • Job Reference: 671815586-2
  • Date Posted: 30 July 2022
  • Recruiter: Celerion
  • Location: Lincoln, Nebraska
  • Salary: $17.00 Per Hour
  • Sector: I.T. & Communications
  • Job Type: Permanent