Job Title: Archives Coordinator
Department: Quality
Location: Onsite; York, UK
Hours Per Week: 37.5
Schedule: Monday - Friday, 8:00 AM - 4:00 PM
SUMMARY
The Archives Coordinator Supports the Quality Assurance department by managing the controlled document and electronic archive lifecycle, ensuring records are accurately catalogued, securely retained, retrievable, transferred to offsite storage, and managed in accordance with applicable procedures, retention requirements, accreditation standards, and regulatory requirements. The role also supports broader Quality Assurance activities, audit readiness, quality metrics, and continuous improvement.
RESPONSIBILITIES
- Independently perform a wide range of activities to support the Quality Assurance department and help achieve and maintain applicable accreditation, standards, and regulatory requirements.
- Maintain current awareness of applicable standards, laws, and guidelines.
- Provide input to the development of Quality Assurance Standard Operating Procedures and processes, the Quality Manual, and other organizational procedures and processes where required.
- Manage the controlled document and electronic archive system to ensure accurate and complete cataloguing, timely retrieval, timely transfer of documents to offsite storage, and compliance with procedural timeframes.
- Manage the document archive lifecycle, including the archiving of controlled documents, forms, templates, study-specific documentation, laboratory source data, and other records considered essential to a clinical trial.
- Manage the archiving of electronic data.
- Perform quality checks of documentation prepared for archiving to ensure records are appropriately catalogued before transfer to an offsite commercial archive.
- Maintain an internal record of archived documents held onsite and within commercial archive facilities.
- Run reports to monitor compliance with archive lifecycle requirements, including storage duration, accuracy of record descriptors, retention periods, and expiration dates for destruction of stored records.
- Support adherence to site quality metrics, including timely completion of assigned internal and vendor audits, Quality Issues, CAPAs, audit responses, and site training.
- Participate in and support client, regulatory, and subcontractor audits.
- Support processes to ensure customer complaints and internally identified Quality Issues are appropriately raised and handled.
- Assist with Lean/Six Sigma and other process improvement activities.
- Collaborate with Archivists across the organization to support a global archiving network where required.
- Participate in Continuous Professional Development.
- Perform other duties as assigned.
MINIMUM QUALITIFICATIONS
- High school diploma or equivalent, or five GCSE grades C or above, including Maths, English, and Science, required.
- Minimum one year of experience in a relevant role required.
PREFERRED QUALIFICATIONS
- Experience in Laboratory Quality Assurance, a pharmaceutical organization, or a Clinical Research Organization (CRO) preferred.
- Knowledge of and demonstrated experience applying Good Clinical Practice (GCP) guidance preferred.
- Good organizational skills.
- Good written and verbal communication skills.
- Good time management skills.
- Ability to work independently and as a team member.
PHYSICAL REQUIREMENTS:
Moderate - These roles require a combination of movement and stationary work, including frequent standing, walking, and moderate lifting (up to 50 lbs.). Tasks may involve repetitive reaching, bending, pushing, or pulling, along with maintaining awareness in high-traffic or operational areas. Visual focus and spatial awareness are critical in facilities, logistics, or support settings. Emotional demands include managing interruptions, prioritizing tasks, and maintaining compliance with safety standards. Environmental exposures may include equipment noise, shared workspaces, and occasional proximity to hazardous areas. Physical capability screening may be required.
Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.
