Study Director - Ecotoxicology

Study Director - Ecotoxicology
LabCorp
Huntingdon, United Kingdom
Job Responsibilities:
Perform the duties of a Study Director/Principal Investigator for studies, including studies for all test organisms following acute and chronic guidelines
Ensure that a Study Plan conforms with the intentions of the study design agreed with the Sponsor is prepared, signed and circulated and all standard test methods meet the current requirements of specific regulatory or test guidelines
Hold study start-up meetings, to ensure all key staff are conversant with all aspects of the study and to resolve any issues before treatment is started, to prevent unnecessary use of animals where applicable
Ensure that test and control items have been suitably tested for identity, stability etc. and that all necessary technical data regarding known toxicity, hazards of the test item or related materials have been obtained from literature searches. Ensure that technical staff are aware of known hazards relating to a particular test item
Ensure that all test organisms are in good state of health and to ensure that the regulations laid down in their Personal Licence (Animals (Scientific Procedure) Act 1986) and in the Project Licence are not exceeded
Monitor the status of observations made during the study and ensure the responses are fully documented. Maintain an overview of the implication of these observations
Data review to ensure the study is compliant with GLP (Good Laboratory Practice) and suitable responses/actions are made following Quality Assurance Audit
Be aware of the study status, anticipate problems that may affect the schedule date, purpose or integrity of the study and make interim decisions regarding necessary amendments, to document such changes and to agree them with the Study Sponsor. Communicate with the Sponsor and Departmental and Project Management as required with particular regard to problem areas which may affect completion date or content of the study
Prepare draft and final reports ensuring the report is concisely and accurately written, reflects the raw data and includes all relevant information
Transfer all study data and reports to the Archive in a timely manner following the issue of the final report, in accordance with Company procedures and SOPs
Maintain monitoring system such that the information is up to date and communicate with Analytical Support in the conduct of studies
Where appropriate co-ordinating the supply of animals, test vessels and equipment in conjunction with other members of staff thereby ensuring their availability for study start up
To be fully aware of the Codes of Practice relating to use of laboratory animals
Contribute to the general management of the Ecotoxicology department in areas outside of that required as a Study Director
Travel as necessary, or to be available in-house to meet current and prospective sponsors to discuss existing and future studies
Keep up-to-date with trends in relevant areas of Ecotoxicology.Review specific topics as necessary so as to be able to discuss with Sponsors
Assist in the training, supervision and mentoring of technical staff and trainee Study Directors
Provide advice and support to internal and external customers relating to any study and non‑study related topics
Minimum Qualifications:
Degree in Environmental Sciences or Ecotoxicology
Additional Job Standards:
Significant experience within a Study Director role in Ecotoxicology
Working knowledge of GLP and regulatory guidelines
Skilled in data interpretation and report writing for studies
Skilled in customer service communication
Proficiency in project management skills
Ability to conduct literature review
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LabCorp