Study Coordinator Pre-clinical services Full-time Job

Individual has responsibility for coordinating the activities of routine and non routine studies in compliance with appropriate company standards, GLP, GCP, GMP and regulatory guidelines specified in the study plans, protocols, or work agreements governing the work in which they are involved in a timely, efficient and quality manner.

Responsibilities/Duties

Individual Contributor

B. People Responsibilities: Assists with training and mentoring of less experienced staff

C. Essential Job Duties: 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. Proactively communicates and interacts with study team SD' s and operational staff to ensure key milestones are achieved Serves 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. Assists in the development and maintenance of standard report/table formats as required 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. Ability to manage increasingly more complex projects and study designs and/or increased study load Responsible for and drives report production through finalisation, including archiving of data as appropriate. Prepares for and participates in routine client visits under direction of the SD/PI. Learns to host routine client visits and interacts/communicates with client as necessary. Maintains an awareness of the financial status of ongoing studies, including workscope changes Begins to act as a basic project coordinator for assigned clientss across the metabolism discipline Performs other related duties as assigned.

Expectations

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 Assists in evaluating the effectiveness of current practices and contributes ideas for solutions to prevent errors and improve efficiencies Remain up to date in area of knowledge and continuously improve technical and interpersonal skills Places organizational goals before personal interests and demonstrates the ability to engage in team building Supports and encourages others in their work Establishes clear plans to meet short and medium term requirements for projects Anticipates issues/obstacles which may prevent meeting project/department objectives and identifies solutions to overcome difficulties 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 with no or minimal supervision

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