The purpose of the Quality Assurance Specialist is to ensure all data collected is reviewed for quality control (QC) and is compliant with study and non-study regulations, including, but not limited to the study protocol, HIPAA, OSHA, GCP, ICH guidelines and internal Standard Operating Procedures (SOPs). The Quality Assurance Specialist will play an integral role in helping the site maintain accuracy in data collection and quality in data management. They will work closely with the study team and investigators.
Some essential job functions include:
- Assist with the development, revision and implement SOP’s, policies, guidance and checklists in accordance with state and federal regulations.
- Oversee the training, skill development and performance of staff with a focus on team building and leadership.
- Provides education to study site staff to promote the responsible conduct of research
- Plans, schedules, and conducts internal quality assurance audits of the processes, procedures, and controls employed in the design, conduct, and analysis of clinical trials
- Communicates observations to clinical investigators, senior study coordinators, training supervisor, and management
- Reviews essential documents such as original source data, medical records, informed consent
forms and other regulatory documentation pertinent to studyPerform quality assurance review of protocol build out in clinical trial management system and ensure it is compliant to protocol language and schedule of events.
- Perform 100% review of all screened subjects to present to Investigators to determine study eligibility prior to randomization.
- Continued eligibility confirmation for randomized subjects.
- Review of ICF and medical records.
- Review data for screen failures.
- Upload records to the clinical trial management system.
- Identify and provide regular updates of non-compliance trends including critical or major findings to the Director of Quality Assurance.
Salary and Benefits:
- The starting salary range for this position will be commensurate with experience.
- At least 5 years of experience in clinical research and preferably healthcare background with knowledge of medical terminology.
- Bachelor’s degree or higher in a field related to health science preferred.
- Clinical research, quality control, and compliance
- Attention to detail.
- Proactive at identifying and addressing issues in real time
- Adaptability in an environment of frequent change
- Proficiency in all Microsoft Office applications (Word, Excel, Outlook, Powerpoint)
- Superior communication and organizational skills
- Proven teamwork skills
- Must be able to work independently following training
- Ability to interpret clinical research protocols
Job Type: Full-time