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 Study Coordinator 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.
- Drafts protocols, amendments and study schedules as appropriate using study outline or client supplied information
- Reviews study compliance against protocol, SOP and regulatory agency guidelines
- Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable.
- Participates in and assists SD/PI with pre-initiation and other study related meetings as required
- Reviews progress and study status against initial work plan – maintains CMS with accurate schedules.
- Communicates and interacts with study team (SD’s and operational staff)
- Learns to serve as the primary contact in communication and interaction with other departments and clients as applicable
- Maintains well documented, organised and up-to-date study files including study schedule, protocol and correspondence.
- Assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.
- Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
- Suggests revisions to standard report and/or table formats
- Assists in interpreting and evaluating data for reports
- Participates in the peer review process for scientific reports
- Reviews QAU report audits with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.
- Reviews client comments with SD/PI and ensures that all necessary report/raw data clarifications are completed.
- Learns to manage increasingly complex projects and study designs
- Responsible for report production through finalisation, including archiving of data as appropriate.
- Participates in routine client visits under direction of the SD/PI. Interacts/communicates with client as necessary.
- Maintains an awareness of the financial status of ongoing studies, including workscope changes
- Performs other related duties as assigned.
- Consistently and continuously responds efficiently to requests (delivers high quality output on time)
- Builds positive relationships with both internal/external clients
- Uses experience and knowledge to contribute to design of new process or program in primary area of work
- Works with the team to identify obstacles to change
- Recognises changing situations and priorities and adapts accordingly
- 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
- Places organizational goals before personal interests and demonstrates the ability to engage in team building
- Supports and encourages others in their work
- Ability to schedule daily tasks to coincide with own study deadlines
- Ability to recognise deviations from normal results and inform Study Director and/or management of any problems that may affect integrity of the data
- Ability to recommend modifications to routine procedures to adapt to problems in primary area
- Ability to understand the scope of a study (primary area of work) and be able to complete tasks with no or minimal supervision