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Job Description
The Role
To timely and accurately create / update the Activity Schedule and timetables necessary to conduct clinical studies successfully
To ensure thorough understanding of the clinical protocol’s schedule of events and staffing requirements
To ensure operational efficiency and safety through correct allocation of appropriately skilled and qualified staff
To comply & adhere to GCP guidelines and regulations as required of this role.
Main Tasks and Responsibilities
Thoroughly read and understand the clinical protocol and build a schedule of events/activities (Activity Schedule) in accordance with protocol requirements and internal SOPs
Liaise with team members including Clinical Scheduler, Clinical Lead, Clinic Manager, Investigator, Database Programmer, Laboratory Lead, and Project Manager when building Activity Schedule
Participate in protocol meetings to discuss requirements for the Activity Schedule (e.g., dose time, stagger interval, priority of assessments, non-standard activities, etc)
Distribute each version of the activity schedule (draft and final) to the project team
Deal and manage effectively any last minute or unexpected amendments to the Activity Schedule
Ensure any revision to the final activity schedule is posted on the designated shared folder and changes communicated timely to appropriate project team members
Provide administrative support to Clinical Leads as needed
Assist with preparing and managing the clinical rota to ensure effective delivery of clinical studies
Deal and manage effectively with queries arising from the rota from staff and relevant departments
Deal and manage effectively any last minute or unexpected amendments to the scheduled rota to ensure absence/sickness or activity level changes do not impact on effective delivery of studies or impact on volunteer safety
Keep clinical senior management informed of all problems and developments regarding the clinical rota
Identify desirable changes or modifications to the Scheduling program, which will enhance or improve the scheduling process
Undertake other duties from time to time to contribute to the effective management of the clinical rotas
Perform study related tasks within scope of training/qualification
Job Demands
The job may involve the following:
Very high concentration of work
Strict and tight deadlines
Having to juggle a range of tasks/issues simultaneously
Working in a hazardous environment with high requirement to follow safety procedures
Working outside normal working hours
Needing to respond to client demands
The Candidate
Experience in a similar role in a fast paced environment
Experience in a healthcare environment preferable
Excellent analytical skills
High levels of attention to detail
Ability to manipulate spreadsheets and databases to a high level
Excellent organisational skills with the ability to prioritise effectively
Proven problem solving skills
Excellent communication and interpersonal skill
Ability to respond quickly to business demands and react to changing circumstances
This Job Description is designed to summarize responsibilities, assist in benchmarking performance, and provide information for job applicants. It is by no means exhaustive and is not intended to restrict a job holder’s development or level of performance.
