09 Feb

Associate Document Coordinator Jobs Vacancy at Covance Harrogate

Position
Associate Document Coordinator
Company
Covance
Location
Harrogate ENG
Opening
09 Feb, 2018 10 days ago

Covance Harrogate urgently required following position for Associate Document Coordinator. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Associate Document Coordinator Jobs Vacancy at Covance Harrogate Jobs Details:

Job Overview

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are recruiting for our Early Compound Development Unit team in Harrogate and are currently seeking to hire an Associate Document Coordinator – Metabolism to help support the metabolism-Study Direction team to conduct all work in compliance with appropriate company standards, GLP, GCP, GMP (where appropriate) and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved.

This is a full time permanent position, based in our site in Harrogate.

Job Summary:

Performs and manages activities related to paperwork logistics for the overall department and client deliverables. This includes but is not limited to study finalisation/archival, and basic data access, compilation, proofing, and QC in compliance with appropriate protocol, Standard Operating Procedure (SOPs), regulatory agency guideline, and client requirements in a timely, efficient, and quality manner.

Essential Job Duties:

  • Performs general administrative tasks to support the department
  • Develops understanding of study outlines, study protocols/amendments, study schedules, regulatory requirements, and Covance SOPs/P&Ps as they pertain to client deliverables (i.e. shipping, archival, data retrieval, and compilation etc.)
  • Develops understanding of client-specific requirements for cover letters, inventories, or additional materials, as appropriate
  • Performs format Quality Control (QC) on protocols and amendments prior to distribution
  • Performs internal and external distribution of definitive protocols and amendments as a PDF document and distributes to sponsor, Study Director (SD) & Quality Assurance (QA) as appropriate
  • Compiles and maintains appropriate storage of wet signature pages
  • Maintain departmental data store for cleanliness & data organisation
  • Maintains well documented, organized and up-to-date study files/data skips including correspondence
  • Schedule and participate in study related meetings, take and distribute meeting minutes
  • Prepares study schedule requests/changes based on input from SD/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable
  • Reviews progress and study status against initial work plan – maintains CMS with accurate schedules
  • Ensure department master schedule is up to date
  • Maintain departmental eTracking system
  • Collates study data from all necessary departments & ensures each package of data is assigned a tracking ID & tracked accordingly
  • Proof checks data tables and figures prepared by others
  • Performs format QC on draft, final and PDF reports prior to distribution ensuring that the most recent template has been used on each occasion
  • Performs internal and external distribution of draft & final reports and distributes to sponsor, SD & QA as appropriate
  • Tracks on time reporting as a departmental metric & provides analysis of the data
  • Prepares required paperwork for document and/or supply shipments in a timely, efficient, and error-free manner

  • Completes paper and electronic study archiving within 2 days of finalisation
  • Appropriately file and store archive summary forms and ensure personnel such as the SD & Application Administrator (AA)'s are notified of acceptance into CSR
  • Maintains departmental records and notifies necessary personnel of study finalisation/archival
  • Performs other related duties as assigned.

Expectations:

  • Consistently and continuously responds efficiently to requests (delivers high quality output on time)
  • Contributes ideas and thoughts to enhance service and improve processes
  • Provides constructive feedback to SD, Study Supervisor (SS), team and/or management
  • Follow instructions, SOPs and protocols that apply to current role to complete assigned tasks and projects
  • Demonstrates ability and desire to learn and develop self
  • Demonstrates a positive attitude regarding challenges with the ability to persevere and solve problems as they occur
  • Informs SD and SS of any unforeseen circumstances that may affect the integrity of the study.
  • Places organizational goals before personal interests and demonstrates the ability to engage in team goals
  • Supports and encourages others in their work
  • Builds positive relationships with both internal/external clients
  • Works with the team to identify obstacles to change
  • Recognises changing situations and priorities and adapts accordingly
  • Assists in evaluating the effectiveness of current practices and contributes ideas for solutions to prevent errors and improve efficiencies
  • Develop an area of knowledge within the department and continuously improve technical and interpersonal skills
  • Shifts ideas and behaviours to keep pace with changing business needs
  • Motivates self and others to assure timely delivery of client expectations
  • Actively promotes collaboration between groups
  • Ability to plan, prioritise, and manage a workload and the associated responsibilities.
  • Serves as a contact, along with the SD, in communication and interactions with other departments and clients, with assistance as applicable.
  • Communicates and interacts with study team (SD’s and operational staff)
  • Manages multiple projects at any given time.
  • Proficient in use of necessary computer systems
  • Works under supervision and guidance of more experienced colleagues
Education / Qualifications
  • Good general education A’Levels/HNC level with 1 year of appropriate experience. Relevant experience may be substituted for academic qualifications.
Experience
  • Ability to utilise word processing, databases, spreadsheets, and specialised software on personal computers.
  • Experience in document production/publishing, and/or science preferred


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