Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Quality Assurance Specialist to support the National Institutes of Health (NIH) in Bethesda, MD. This position will support a hybrid schedule, that will require weekly on-site work in Bethesda, MD.
This is a full-time, long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans.
- Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan.
- Access to NIH's unparalleled resources and niche scientific initiatives.
- Learn more about what Kelly can do for you at
TASKS/SERVICES:
- Provide support to the Quality Assurance (QA) Manager for clinical quality assurance activities.
- Provide Quality Assurance document management/control support in electronic clinical quality assurance systems (i.e Master Control).
- Participate in quality assurance activities related to the close out of projects (such as file audits, tracking, reconciliation and transfer of clinical study files (onsite and offsite).
- Transmit safety information communications from study drug manufacturers providing study drug for sponsored clinical trials to Regulatory Management Center (RMC).
- Participate in the development and implementation of written project work instructions and standard operating procedures to harmonize operational processes internally at and in collaboration with the Regulatory Management Center; identify new processes, build teams, development and negotiation of ideas from concept to written and approved process.
- Perform quality assurance review of Office of Regulatory Affairs (ORA) documents to include (but not limited to) contract agreements, audit reports, and other related clinical documents.
- Perform reconciliation of receipt/distribution of safety information at request of ORA staff and/or study drug manufacturers.
- Respond to queries regarding safety information received/distributed.
- Lead ORA weekly staff meetings (schedule, generate agenda, update action items).
- Serve as the primary QA point person for ORA archive files stored at Iron Mountain for long term storage of regulatory documents.
- Manage distribution and tracking of all official Health Authority (HA) correspondence (US and Other) to include HA submissions, reporting.
- Assume responsibility for the ORA file room (HA communication) by taking charge of tasks related to organization, space allocation and archiving with emphasis on maximal utilization of space.
- Manage all incoming documents (HA Letter, faxes, etc.) to include scanning, distribution to the RMC and filing
REQUIREMENTS
- Master's Degree in Public Health or a related discipline
- Minimum three (3) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree.
- Master Control, or similar document system is preferred.
- Document control experience is required.