Quality Control Specialist

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. 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 studyEnsure QC reviews are completed in accordance with study specific timelinesEnsure consistent and complete review of source data by completing a Study Information Document indicating all study specific QC review requirementsMeet 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/PGsPrepare and manage study materials including but not limited to Source Data Storage Binder /FilesReview 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 protocolClinical 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/PGsAll deviations and documentation errors are sent to clinical staff for correction and updates as applicableEnsure data corrections are completed according to GCP guidelines, and Celerion SOPs/PGsComplete a Final QC to ensure all source data is accounted for and has been QC reviewedCompile and sort all screening failures - not on study (NOS) - dataArchive study source documents (as needed) 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 preferredMedical Terminology Training preferredExcellent oral and written communication skillsAbility to organize and manage multiple prioritiesExperience working in an environment with complex processes and defined criteriaExcellent time managementProficient in MS Office applications requiredCelerion 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.

Created: 2021-11-29