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Title: Study Director
Department: Toxicology Operations
Location: Chengdu, China
Reports to: Chief Scientific Officer
Qualifications:
Masters or Doctoral degree in toxicology or related field or DVM with relevant experience
Expertise in toxicology, reproductive toxicology, immunology, pharmacology, and/or related fields
D.A.B.T. or working toward certification
Excellent computer, communication and writing skills (previous publication preferred)
Ability to work independently
Study Protocol Responsibilities:
Communicate with the Sponsor to prepare study protocols
Arrange for the required amount of test article to be provided
Approve study formulation procedures
Approve study milestone schedule, dose preparation schedule, report schedule and calendar
Prepare study protocols and amendments, obtain appropriate signatures, arrange for distribution and QA audit,
if required
Study Conduct Responsibilities:
Responsible for overall study management including technical conduct of the study, interpretation,
documentation and reporting of results
Primary point of contact with Sponsor on all study related issues. If a project manager has been assigned,
the Study Director will instead interact directly with the project manager, unless otherwise directed
Arrange for the pre-initiation meeting with all of the involved staff
Be present daily to observe animals and/or discuss findings with staff. Observe initial dose preparation, first day
of study and other key study events (e.g. necropsy, clinical pathology sampling)
Observe study animals on at least a weekly basis
Review all scheduled study data on a frequent basis
Perform QC on data from selected studies on a weekly basis
Respond to QA audits
Review study conduct to ensure compliance with the protocol, research proposals, and standard
operating procedures
Ensure that all study events, e.g. animal ordering, randomization, shipping of samples, necropsy, are completed
as scheduled
Coordinate study events with the subcontractors as appropriate
Respond to all quality assurance audits in the required time frame
Attend regularly scheduled meetings to include staff, pre-initiation, and pre-necropsy meetings
Reviews training files of all technical staff
Provide input on staff performance reviews
Ensure compliance with all facility health & safety requirements
Monitor budget for the study
Submit IACUC review form
Study Report Responsibilities:
Communicate study findings to the Sponsor on a frequent basis
Respond to all quality assurance audits in the required time frame
Oversee report writing process including writing summary, results, and conclusions, reviewing drafts, receiving
and addressing client comments, interacting with contributing scientists as necessary, and approving the
final report
Ensure that all raw data and specimens are archived upon finalization of the report
Professional / Corporate Responsibilities:
Assist Business Development (BD) staff in proposal development
Participate in some BD meetings and presentations
Perform job functions in accordance with departmental and corporate mission
Develop and review new procedures, technologies, and SOPs as required
Approve/Develop new procedures and technologies as required, including development of new standard
operating procedures and/or forms
Assist in developing Health & Safety, AAALAC, and facility programs
Publish the results of the studies in peer-reviewed journals
Maintain an active involvement in professional toxicology organizations
Be knowledgeable in domestic and international regulatory requirements
Email or fax your resume today to:
HR@frontierbsi.com or (301) 515-5562
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