Quality Assurance Specialist Position Available In Knox, Tennessee

Quality Assurance Specialist Alliance For MultiSpecialty Research

LLC – 3.0

Knoxville, TN Job Details Full-time $26.40 – $31.25 an hour 9 hours ago Qualifications Microsoft Excel Management Clinical trials Computer skills Senior level Communication skills Full Job Description 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 processes 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 Clinical’s Core Values:

United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere Position type: Remote The QA Specialist will report directly to the Director of Quality Assurance.

Classification:

Non-Exempt Primary Responsibilities:

Proactively engage in risk-based approach in the review of protocols and other study related documents (e.g., study reference manual, EDC screenshots, eCRF guidelines) to assess potential issues that may arise. Ensure site compliance with SOPs, site specific work processes, and all state and federal regulations. Review site specific work processes prior to approval to ensure compliance with SOPs and recommend changes based on issues that may arise. Ongoing review of SOPs to ensure compliance and suggest revisions as necessary to the Director of QA. Identify when new SOPs are needed and make recommendations to the Director or QA. Regularly review site ICF process to ensure compliance. Work with training colleagues to develop training documentation as needed for clinical trial staff, based on findings from internal study audits, CAPAs, CRA reports, etc. Work with site management and applicable site staff to provide guidance to address quality related issues. Identify areas of risk exposure and provide recommendations for minimizing risk. Conduct risk assessments prior to study start up as assigned. Review CRA reports for outstanding issues prior to next visit; discuss with appropriate study team member(s). Lead the preparation for Sponsor and FDA audits. Host Sponsor and FDA Audits. Lead the follow up from Sponsor and FDA audits, including working with appropriate site staff to complete the audit follow up response, ensuring the completion of any CAPAs associated with the audit and following up to ensure the CAPA is proven effective and closed. Routinely conduct Internal Audits in accordance with the Quality Management Plan and report findings to the Director of QA, General Manager and Site Manager. Promptly notify Director of QA of any upcoming Sponsor or Regulatory audits. Travel to sites as needed to host Sponsor and FDA audits. Travel to sites as needed for in-person internal audits as needed. Conduct/oversee CAPA investigations. Compose a complete and accurate CAPA to present to the Site Manager and Director of QA for review and approval. Regularly review protocol deviations for assigned sites and submit to the Director of Quality Assurance. Attend and participate in quality review/oversight meetings with the Director of Quality Assurance. Projects or duties as assigned by Director of Quality Assurance Other duties as assigned.

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. AMR Clinical 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. •This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.