Position Overview
The Quality Assurance Specialist promotes an all-encompassing emphasis on quality through each phase of the research process. This position is responsible for establishing and maintaining systematic review of process and documentation to ensure compliance with the FDA’s Code of Federal Regulations, ICH Guidelines for Good Clinical Practice, as well as the HIPPA Privacy and Security Rules. The Quality Assurance Specialist’s focus will center on measures to prevent, detect, investigate, assess and correct errors and violations associated with the conduct of clinical trials.
To consistently embody AMR’s Core Values:
- Excellence and Consistency
- Collaborative Innovation
- Respect for our Subjects, Sponsors and Team Members
- Community
- Unimpeachable Ethics
The Quality Assurance Specialist reports to the General Manager/Team Lead and or Site Manager with a dotted line to the Quality Assurance Manager.
Classification: Non-Exempt
Primary Responsibilities:
- Review source docs vs CRF’s; ask questions and prepare summaries; discuss with CRC
- Create new process documents, study logs, etc., as needed. Review process documents and make changes at staff request; recommend changes based on issues that may arise from studies. (this includes developing training documentation for all clinical staff)
- Review study visits on a continual basis to ensure accurate documentation and
- protocol adherence.
- Review CRA reports for outstanding issues prior to next visit; discuss with appropriate study team member(s).
- Work with CRCs to provide guidance to address quality related issues. Identify areas of risk exposure and provide recommendations for minimizing risk. Solicit feedback from CRAs following monitor visits.
- Ongoing reviews of SOPs for compliance and revisions and/or additions needed; identify when new SOPs are needed (determine if memo to file or guidance document will meet the immediate need and make recommendations to management).
- Conducts 100% review of all Informed Consents
- Assist on site qualification visits and other regulatory-related issues as they arise.
- Create new source docs and review of source docs from sponsor (compared to CRF).
- Assist with the completion of Sponsor and FDA audit preparation
- Participate in site initiations and close out meetings.
- Routinely conduct Internal Audits and report findings to General Manager and/or Site Manager and Quality Assurance Manager.
- Promptly notify Quality Assurance Manager of any upcoming Sponsor or Regulatory audits.
- Conduct/oversee CAPA investigations.
- Ensure site compliance with local SOPs, AMR MOPs and all state and federal regulations.
- Proactively review protocols and other study related documents (e.g. study reference manual, EDC screenshots, eCRF guidelines) to assess for potential issues that may arise.
- Projects or duties as assigned by Quality Assurance Manager
Desired Skills and Qualifications:
- Successful completion of previous research, healthcare or QA training or equivalent job experience.
- Ability to function independently with minimal supervision, and to consistently exercise discretion and the highest levels of good clinical and other professional judgment.
- Ability to effectively devote keen and acute attention to detail.
- Positive attitude and the ability and desire to work in a company that embraces collaboration and a team approach.
- Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments, i.e. Word, Excel, Internet
- Professional and highly motivated “self-starter” with the ability to exercise initiative.
- Excellent task management and prioritization skills.
- Strong verbal and written communication as well as interpersonal skills.
- Excellent follow up
Alliance of Multispecialty Research does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.