Scientist 1 – Infectious Disease Research
The Scientist 1 is responsible for providing study support for execution of project work in the Drug Development Division (DDV), usually under the direction of a study director or senior study director. The position functions as a subject matter expert within the organization. Individuals in this role will aid in the conduct of studies, compiling and evaluating data, and assembling study files. Individual may function independently as a study director with appropriate experience. In the role of study director, has oversight of the scientific elements of projects to ensure successful completion and/or implementation, land analyzes and reports results for publication or to sponsors. Provides instruction to other members of the project team; and collaborates with other senior members of the staff on projects/research.
· Performs the role of Scientific Subject Matter Expert (SME) on commercial and government contracts.
· Aids senior study directors or serves independently as study director on studies for commercial and government sponsors.
· Drafts protocols, amendments, and departmental notification; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
· Ensures that the protocol and/or scope of work is consistent with the contract.
· Identifies and incorporates exceptions to Good Laboratory Practices (GLP) conduct into GLP study protocols as applicable (e.g. systems/processes that are not validated).
· May create and maintain the study file (electronic) and/or study binders (hard copy).
· Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and assists with conduct of pre-study meetings.
· Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses under the direction of the study director.
· Reviews Standard Operating Procedures (SOP’s) associated with study conduct and incorporates language into the protocol describing procedures or processes when necessary.
· Reviews contract for use in execution of studies and proactively notifies study director or project manager of any issues.
· Observes appropriate safety and study requirements by reading, understanding, and following SOP, GLP requirements and study protocols.
· Performs review of Provantis study setups prior to study director review and approval.
· Participates in all required training.
· Follows GLP Practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
· Manages studies within time and budget constraints.
· Performs other duties as may be required by supervisor.
· Ph.D. or equivalent (e.g. DVM) in life sciences discipline, or MS with at least two (2) years relevant experience, or BS with at least five (5) years relevant experience.
· Knowledge and ability to use the fundamental concepts, practices, and procedures of the particular field of specialization.
· Knowledgeable in or able to master GLP procedures/regulations and application of those guides to studies.
· Effective written and verbal communication skills including correct grammar, spelling, and punctuation. Ability to communicate with stakeholders at all levels internally and externally to the organization.
· Proficient with software applications (Windows, Microsoft Word, Project, Excel or other database software).
· Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
· Working knowledge of or the ability to learn and utilize specialty software applications (e.g., Edstrom, Provantis, laboratory information management systems, etc.).
Work Environment & Conditions
This position works in office and laboratory environments and requires the use of personal protective equipment (PPE) including (but not limited to):
· Eye protection (Safety glasses and/or full face shield)
· Respirator (varies based on tasks and barrier requirements)
· Tyvek/scrub suits
· Nitrile (or equivalent) gloves (varies based on tasks)
· Hearing protection (varies based on tasks)
This position may require the ability to meet all entry requirements, including medical and vaccination requirements for work in both an ABSL-2 and ABSL-3 laboratory environment. Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.